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LDH S.C.E.

by J. D. Assoc. 510(k)

Active United States

510(k) K863068

Overview

The LDH S.C.E. is a lactate dehydrogenase device used in clinical chemistry for nad reduction/nadh oxidation testing.

This device is manufactured by J. D. Assoc. and is authorized under FDA 510K with product code CFJ. It is a Class II device with registration number 8040374 and is not a third-party submission.

AI-generated from registry data, 27 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK863068 Date10 Dec 1986ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
CFJ
Device Class
Class II
Regulation
21 CFR Part 862.1440
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Other devices from J. D. Assoc.

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    Class II

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    Class I

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    Class I

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    Class II

See all devices from J. D. Assoc. →

Questions

  • What is the LDH S.C.E. device used for?

    The LDH S.C.E. is a lactate dehydrogenase device specifically designed for clinical chemistry applications, particularly for nad reduction/nadh oxidation testing. It is manufactured by J. D. Assoc. and is intended for laboratory use in biochemical analysis.

  • What is the regulatory status of the LDH S.C.E. device?

    The LDH S.C.E. device is authorized under FDA 510K with product code CFJ. It is classified as a Class II device with registration number 8040374 and received FDA clearance on December 10, 1986, as substantially equivalent to predicate devices.

  • Is the LDH S.C.E. device reusable or single-use?

    The device data does not specify whether the LDH S.C.E. is designed for single-use or reuse. For proper handling and disposal instructions, users should refer to the manufacturer's documentation or contact J. D. Assoc. directly.

  • What are the specifications of the LDH S.C.E. device?

    The LDH S.C.E. is a lactate dehydrogenase device with no specific dimensions or technical parameters provided in the device data. It is part of the clinical chemistry product category and is manufactured by J. D. Assoc. in Montclair, New Jersey.