510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K861835Substantially Equivalent

Microtrak Neiserria Gonorrhoeae Culture Test

Syva Co., Palo Alto CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861835 is the FDA 510(k) clearance record for MICROTRAK NEISERRIA GONORRHOEAE CULTURE TEST, a class II device, cleared for Syva Co. on under FDA product code GTH (Antiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae). FDA records list 140 510(k) clearances for Syva Co., from to . As of , FDA records show no recalls naming K861835.

Clearance record

Decision date
Received
(16 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
Syva Co. 900 Arastradero Rd., Palo Alto CA
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