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Modified Apsara Clinical Diagnostic Analyzer

by Datachem, Inc. 510(k)

Active United States

510(k) K900788

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK900788 Date5 Jul 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  • Withdrawn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
CEM
Device Class
Class II
Regulation
21 CFR Part 862.1600
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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