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Technicon Chem I System Carbon Dioxide Method

by Technicon Instruments Corp. 510(k)

Active United States

510(k) K903305

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK903305 Date27 Sep 1990ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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
KHS
Device Class
Class II
Regulation
21 CFR Part 862.1160
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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