510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K921176Substantially Equivalent

Vitek Immunodiagnostic Assay System

Vitek Systems, Inc., Hazelwood MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921176 is the FDA 510(k) clearance record for VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM, a class I device, cleared for Vitek Systems, Inc. on under FDA product code CEP (Radioimmunoassay, Luteinizing Hormone). FDA records list 39 510(k) clearances for Vitek Systems, Inc., from to . As of , FDA records show one recall naming K921176.

Clearance record

Decision date
Received
(28 days to decision)
Product code
CEP Radioimmunoassay, Luteinizing Hormone
Regulation
21 CFR 862.1485
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Vitek Systems, Inc. 595 Anglum Dr., Hazelwood MI
510(k) summary
Summary
Third party review
No

Clearances, product code CEP

Trailing 12 months

FDA records hold no clearances under product code CEP in the trailing twelve months.

FDA records show no clearances under product code CEP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CEP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260