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Reagent, Amylase Lipase

by Bd Becton Dickinson Vacutainer Systems Preanalytic

510(k) K770400

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK770400 Date26 Apr 1977ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KHM
Device Class
Class II
Regulation
21 CFR Part 862.1070
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Reagent, Amylase Lipase is a nephelometric amylase reagent used in clinical chemistry for the measurement of amylase and lipase activity. It is classified as a Class II medical device under regulation number 862.1070 with product code KHM.

The reagent was cleared through the FDA 510(k) process under submission K770400 on April 26, 1977, and is substantially equivalent to a legally marketed device. It is manufactured by Becton Dickinson Vacutainer Systems Preanalytic and intended for use in clinical laboratory settings.

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