510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K931224Substantially Equivalent

Vidas Total Ige (Ige) Assay

Biomerieux Vitek, Inc., Rockland MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K931224 is the FDA 510(k) clearance record for VIDAS TOTAL IGE (IGE) ASSAY, a class II device, cleared for Biomerieux Vitek, Inc. on under FDA product code DGP (Ige, Fitc, Antigen, Antiserum, Control). FDA records list 49 510(k) clearances for Biomerieux Vitek, Inc., from to . As of , FDA records show no recalls naming K931224.

Clearance record

Decision date
Received
(71 days to decision)
Product code
DGP Ige, Fitc, Antigen, Antiserum, Control
Regulation
21 CFR 866.5510
Device class
Class II
Review panel
Immunology
Applicant
Biomerieux Vitek, Inc. 1022 Hingham St., Rockland MA
510(k) summary
Summary
Third party review
No

Clearances, product code DGP

Trailing 12 months

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

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