510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800328Substantially Equivalent

Neisseria Gonorrhoeae Fluoro-Kit

Clinical Sciences, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K800328 is the FDA 510(k) clearance record for NEISSERIA GONORRHOEAE FLUORO-KIT, a class II device, cleared for Clinical Sciences, Inc. on under FDA product code GTH (Antiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae). FDA records list 30 510(k) clearances for Clinical Sciences, Inc., from to . As of , FDA records show no recalls naming K800328.

Clearance record

Decision date
Received
(20 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
Clinical Sciences, Inc. 803 N. Front St. Suite 3, Mchenry IL
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