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Autogrouper 16C Sys Automated Reag

by Technicon Instruments Corp. 510(k)

Active United States

510(k) K834149

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK834149 Date9 Mar 1984ClearedStatusActive

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  • Withdrawn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
GMQ
Device Class
Class II
Regulation
21 CFR Part 866.3820
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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