510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K874544Substantially Equivalent

Snap(r) Campylobacter Culture Ident Diagnostic Kit

Molecular Biosystems, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K874544 is the FDA 510(k) clearance record for SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT, a class I device, cleared for Molecular Biosystems, Inc. on under FDA product code LGO (Test, Leukocyte Typing). FDA records list 4 510(k) clearances for Molecular Biosystems, Inc., from to . As of , FDA records show no recalls naming K874544.

Clearance record

Decision date
Received
(283 days to decision)
Product code
LGO Test, Leukocyte Typing
Regulation
21 CFR 864.7675
Device class
Class I
Review panel
Hematology
Applicant
Molecular Biosystems, Inc. 10030 Barnes Canyon Rd., San Diego CA
Third party review
No

Clearances, product code LGO

Trailing 12 months

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

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