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

Antigen, C. Difficile

21 CFR 866.2660 / Microbiology
FDA source (opens on fda.gov)

MCB is the FDA product code for Antigen, C. Difficile, a class I device type, regulated under 21 CFR 866.2660. As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
MCB
Device name
Antigen, C. Difficile
Regulation
21 CFR 866.2660
Device class
Class I
Review panel
Microbiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
10
Ingested recalls
4

Clearances, product code MCB

By decision year
10 clearances under product code MCB with a decision year between 1984 and 2013, 2011 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code MCB by decision year
YearClearances
19841
19901
19911
19921
19961
19981
20061
20112
20131

Applicants with the most clearances

Product code MCB
Applicants holding the most 510(k) clearances under product code MCB
ApplicantClearances
Meridian Bioscience Inc2
Meridian Diagnostics, Inc.2
Bartels Immunodiagnostic Supplies, Inc.1
Baxter Healthcare Corporation1
bioMerieux, Inc.1
Biosite Incorporated1
Techlab, Inc.1
Unipath, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code