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

Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control

21 CFR 864.7340 / Hematology
FDA source (opens on fda.gov)

DAT is the FDA product code for Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 864.7340. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DAT
Device name
Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control
Regulation
21 CFR 864.7340
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
2
Ingested recalls
0

Clearances, product code DAT

By decision year
2 clearances under product code DAT with a decision year between 1978 and 1994, 1978 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DAT by decision year
YearClearances
19781
19941

Applicants with the most clearances

Product code DAT
Applicants holding the most 510(k) clearances under product code DAT
ApplicantClearances
Medishield, Inc.1
bioMerieux, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

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