510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912791Substantially Equivalent

Salmonella O Grouping Antisera Set

S.M.I. Medical, Inc., Avon MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912791 is the FDA 510(k) clearance record for SALMONELLA O GROUPING ANTISERA SET, a class II device, cleared for S.M.I. Medical, Inc. on under FDA product code GRM (Antisera, All Groups, Salmonella Spp.). FDA records list one 510(k) clearance for S.M.I. Medical, Inc. As of , FDA records show no recalls naming K912791.

Clearance record

Decision date
Received
(468 days to decision)
Product code
GRM Antisera, All Groups, Salmonella Spp.
Regulation
21 CFR 866.3550
Device class
Class II
Review panel
Microbiology
Applicant
S.M.I. Medical, Inc. 491 W. Main St., Avon MA
510(k) summary
Statement
Third party review
No

Clearances, product code GRM

Trailing 12 months

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

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