510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K896635Substantially Equivalent

Viral Respiratory Indirect Fluores. Mono. Antibody

Baxter Healthcare Corporation, Bellevue WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K896635 is the FDA 510(k) clearance record for VIRAL RESPIRATORY INDIRECT FLUORES. MONO. ANTIBODY, a class I device, cleared for Baxter Healthcare Corp on under FDA product code GNW (Antisera, Cf, Influenza Virus A, B, C). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K896635.

Clearance record

Decision date
Received
(72 days to decision)
Product code
GNW Antisera, Cf, Influenza Virus A, B, C
Regulation
21 CFR 866.3330
Device class
Class I
Review panel
Microbiology
Applicant
Baxter Healthcare Corp P.O. Box 3093, Bellevue WA
Third party review
No

Clearances, product code GNW

Trailing 12 months

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

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