510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K112048Substantially Equivalent

Immunocard C. Difficile Gdh

Meridian Bioscience Inc, Cincinnati OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K112048 is the FDA 510(k) clearance record for IMMUNOCARD C. DIFFICILE GDH, a class I device, cleared for Meridian Bioscience, Inc. on under FDA product code MCB (Antigen, C. Difficile). FDA records list 38 510(k) clearances for Meridian Bioscience, Inc., from to . As of , FDA records show no recalls naming K112048.

Clearance record

Decision date
Received
(151 days to decision)
Product code
MCB Antigen, C. Difficile
Regulation
21 CFR 866.2660
Device class
Class I
Review panel
Microbiology
Applicant
Meridian Bioscience, Inc. 3471 River Hills Dr., Cincinnati OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MCB

Trailing 12 months

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

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