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

Complement C1q, Antigen, Antiserum, Control

21 CFR 866.5240 / Immunology
FDA source (opens on fda.gov)

DAK is the FDA product code for Complement C1q, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5240. As of , FDA records hold 28 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
DAK
Device name
Complement C1q, Antigen, Antiserum, Control
Regulation
21 CFR 866.5240
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
28
Ingested recalls
3

Clearances, product code DAK

By decision year
28 clearances under product code DAK with a decision year between 1977 and 2003, 1977 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code DAK by decision year
YearClearances
19774
19782
19791
19823
19843
19853
19862
19872
19881
19911
19951
19982
20021
20032

Applicants with the most clearances

Product code DAK
Applicants holding the most 510(k) clearances under product code DAK
ApplicantClearances
Ortho Diagnostic Systems, Inc.3
Biostar Medical Products, Inc.2
Cytotech, Inc.2
Gamma Medical Products, Inc.2
Hyland Therapeutic Div., Travenol Laboratories2
Icl Scientific2
The Binding Site2
American Laboratory Products Company1
Collaborative Research, Inc.1
Cordis US Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code