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

Albumin, Antigen, Antiserum, Control

21 CFR 866.5040 / Immunology
FDA source (opens on fda.gov)

DCF is the FDA product code for Albumin, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5040. As of , FDA records hold 37 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
DCF
Device name
Albumin, Antigen, Antiserum, Control
Regulation
21 CFR 866.5040
Device class
Class II
Review panel
Immunology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
37
Ingested recalls
3

Clearances, product code DCF

By decision year
37 clearances under product code DCF with a decision year between 1977 and 2016, 1988 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code DCF by decision year
YearClearances
19772
19781
19801
19811
19851
19861
19872
19885
19892
19901
19911
19951
19961
19972
20042
20051
20062
20091
20103
20111
20121
20131
20141
20151
20161

Applicants with the most clearances

Product code DCF
Applicants holding the most 510(k) clearances under product code DCF
ApplicantClearances
Kallestad Diag, A Div. of Erbamont, Inc.4
Siemens Healthcare Diagnostics Inc.3
Roche Diagnostics GmbH3
The Binding Site Group Ltd.3
Beckman Instruments, Inc.2
Behring Diagnostics, Inc.2
Technicon Instruments Corp.2
Unipath, Ltd.2
Beckman Coulter Ireland Inc1
Cooper Biomedical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 33 companies shown, in name order