510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K880076Substantially Equivalent

G-Mark

Bainbridge Laboratories, Inc., Bainbridge Island WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K880076 is the FDA 510(k) clearance record for G-MARK, a class II device, cleared for Bainbridge Laboratories, Inc. on under FDA product code LIC (Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae). FDA records list 2 510(k) clearances for Bainbridge Laboratories, Inc., from to . As of , FDA records show no recalls naming K880076.

Clearance record

Decision date
Received
(172 days to decision)
Product code
LIC Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae
Regulation
21 CFR 866.3390
Device class
Class II
Review panel
Microbiology
Applicant
Bainbridge Laboratories, Inc. 7861 Day Rd. W., Bainbridge Island WA
Third party review
No

Clearances, product code LIC

Trailing 12 months

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

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