510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K900604Substantially Equivalent

Direct Fluorescent Antibody Reagent for Giardia

Biovir Laboratories, Inc., Benicia CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K900604 is the FDA 510(k) clearance record for DIRECT FLUORESCENT ANTIBODY REAGENT FOR GIARDIA, a class II device, cleared for Biovir Laboratories, Inc. on under FDA product code KHW (Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.). FDA records list one 510(k) clearance for Biovir Laboratories, Inc. As of , FDA records show no recalls naming K900604.

Clearance record

Decision date
Received
(168 days to decision)
Product code
KHW Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
Regulation
21 CFR 866.3220
Device class
Class II
Review panel
Microbiology
Applicant
Biovir Laboratories, Inc. 685 Stone Rd., Unit 6, Benicia CA
Third party review
No

Clearances, product code KHW

Trailing 12 months

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

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