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Apec Glucose Analyzer

by Amdev, Inc. 510(k)

Active United States

510(k) K890524

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK890524 Date15 Mar 1989ClearedStatusActive

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  • Withdrawn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
CGA
Device Class
Class II
Regulation
21 CFR Part 862.1345
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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