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

Haptoglobin, Fitc, Antigen, Antiserum, Control

21 CFR 866.5460 / Immunology
FDA source (opens on fda.gov)

DAB is the FDA product code for Haptoglobin, Fitc, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5460. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DAB
Device name
Haptoglobin, Fitc, Antigen, Antiserum, Control
Regulation
21 CFR 866.5460
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
3
Ingested recalls
0

Clearances, product code DAB

By decision year
3 clearances under product code DAB with a decision year between 1978 and 1991, 1978 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DAB by decision year
YearClearances
19781
19841
19911

Applicants with the most clearances

Product code DAB
Applicants holding the most 510(k) clearances under product code DAB
ApplicantClearances
Gelman Instrument Co.1
Intl. Diagnostic Technology1
The Binding Site1

Companies listing this code with FDA

Companies whose registered establishments list this code

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