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

Antigen, Ebv, Capsid

21 CFR 866.3235 / Microbiology
FDA source (opens on fda.gov)

MCD is the FDA product code for Antigen, Ebv, Capsid, a class I device type, regulated under 21 CFR 866.3235. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
MCD
Device name
Antigen, Ebv, Capsid
Regulation
21 CFR 866.3235
Device class
Class I
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
8
Ingested recalls
0

Clearances, product code MCD

By decision year
8 clearances under product code MCD with a decision year between 1991 and 1999, 1991 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code MCD by decision year
YearClearances
19913
19921
19932
19941
19991

Applicants with the most clearances

Product code MCD
Applicants holding the most 510(k) clearances under product code MCD
ApplicantClearances
Ortho Diagnostic Systems, Inc.3
Zeus Scientific LLC2
Fuller Laboratories, Inc.1
Gull Laboratories, Inc.1
Virion (U.S.), Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code