510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K900546Substantially Equivalent

Bartels Neisseria Gonorrhoeae Direct Fluorescent

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

K900546 is the FDA 510(k) clearance record for BARTELS NEISSERIA GONORRHOEAE DIRECT FLUORESCENT, a class II device, cleared for Baxter Healthcare Corp on under FDA product code GTH (Antiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K900546.

Clearance record

Decision date
Received
(130 days to decision)
Product code
GTH Antiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae
Regulation
21 CFR 866.3390
Device class
Class II
Review panel
Microbiology
Applicant
Baxter Healthcare Corp P.O. Box 3093, Bellevue WA
Third party review
No

Clearances, product code GTH

Trailing 12 months

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

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