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

Gamma Globulin, Fitc, Antigen, Antiserum, Control

21 CFR 866.5510 / Immunology
FDA source (opens on fda.gov)

DAF is the FDA product code for Gamma Globulin, Fitc, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5510. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
DAF
Device name
Gamma Globulin, Fitc, Antigen, Antiserum, Control
Regulation
21 CFR 866.5510
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code DAF

By decision year
1 clearance under product code DAF with a decision year between 1987 and 1987, 1987 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DAF by decision year
YearClearances
19871

Applicants with the most clearances

Product code DAF
Applicants holding the most 510(k) clearances under product code DAF
ApplicantClearances
Boehringer Mannheim Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code DAF.