510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
DANClass II

Fibrinopeptide A, Antigen, Antiserum, Control

21 CFR 866.5350 / Immunology
FDA source (opens on fda.gov)

DAN is the FDA product code for Fibrinopeptide A, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5350. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DAN
Device name
Fibrinopeptide A, Antigen, Antiserum, Control
Regulation
21 CFR 866.5350
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
3
Ingested recalls
0

Clearances, product code DAN

By decision year
3 clearances under product code DAN with a decision year between 1982 and 1988, 1982 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DAN by decision year
YearClearances
19821
19861
19881

Applicants with the most clearances

Product code DAN
Applicants holding the most 510(k) clearances under product code DAN
ApplicantClearances
Altana, Inc.1
American Bioproducts Co.1
Mallinckrodt Critical Care1

Companies listing this code with FDA

Companies whose registered establishments list this code

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