510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K891385Substantially Equivalent

Vitek Immunodiagnostic Assay System (Vidas)

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

K891385 is the FDA 510(k) clearance record for VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS), a class II device, cleared for Vitek Systems, Inc. on under FDA product code DEW (Igg, Antigen, Antiserum, Control). FDA records list 39 510(k) clearances for Vitek Systems, Inc., from to . As of , FDA records show no recalls naming K891385.

Clearance record

Decision date
Received
(40 days to decision)
Product code
DEW Igg, Antigen, Antiserum, Control
Regulation
21 CFR 866.5510
Device class
Class II
Review panel
Immunology
Applicant
Vitek Systems, Inc. 595 Anglum Dr., Hazelwood MI
Third party review
No

Clearances, product code DEW

Trailing 12 months

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

FDA records show no clearances under product code DEW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DEW, 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