510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K954784Substantially Equivalent

Dryside Neisseria

Difco Laboratories, Inc., Livouia MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954784 is the FDA 510(k) clearance record for DRYSIDE NEISSERIA, a class I device, cleared for Difco Laboratories, Inc. on under FDA product code LTS (Test Reagents, Neisseria Gonorrhoeae Biochemical). FDA records list 121 510(k) clearances for Difco Laboratories, Inc., from to . As of , FDA records show no recalls naming K954784.

Clearance record

Decision date
Received
(105 days to decision)
Product code
LTS Test Reagents, Neisseria Gonorrhoeae Biochemical
Regulation
21 CFR 866.2660
Device class
Class I
Review panel
Microbiology
Applicant
Difco Laboratories, Inc. 17197 N. Laurel Park, Livouia MI
510(k) summary
Summary
Third party review
No

Clearances, product code LTS

Trailing 12 months

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

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