510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K820996Substantially Equivalent

Salmonella & Shigella Grouping Sera

Fisher Scientific Company L.L.C., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K820996 is the FDA 510(k) clearance record for SALMONELLA & SHIGELLA GROUPING SERA, a class II device, cleared for Fisher Scientific Co., LLC on under FDA product code GRL (Antigens, All Groups, Salmonella Spp.). FDA records list 89 510(k) clearances for Fisher Scientific Co., LLC, from to . As of , FDA records show no recalls naming K820996.

Clearance record

Decision date
Received
(24 days to decision)
Product code
GRL Antigens, All Groups, Salmonella Spp.
Regulation
21 CFR 866.3550
Device class
Class II
Review panel
Microbiology
Applicant
Fisher Scientific Co., LLC 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GRL

Trailing 12 months

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

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