510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K991268Substantially Equivalent

Gonostat Gonococcal Detection Kit

Sierra Diagnostics, Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991268 is the FDA 510(k) clearance record for GONOSTAT GONOCOCCAL DETECTION KIT, a class II device, cleared for Sierra Diagnostics on under FDA product code LSL (Dna-Reagents, Neisseria). FDA records list one 510(k) clearance for Sierra Diagnostics. As of , FDA records show no recalls naming K991268.

Clearance record

Decision date
Received
(120 days to decision)
Product code
LSL Dna-Reagents, Neisseria
Regulation
21 CFR 866.3390
Device class
Class II
Review panel
Microbiology
Applicant
Sierra Diagnostics 1900 K St. NW, Washington DC
510(k) summary
Summary
Third party review
No

Clearances, product code LSL

Trailing 12 months

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

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