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

Gamma Globulin, Antigen, Antiserum, Control

21 CFR 866.5510 / Immunology
FDA source (opens on fda.gov)

DAH is the FDA product code for Gamma Globulin, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5510. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DAH
Device name
Gamma Globulin, Antigen, Antiserum, Control
Regulation
21 CFR 866.5510
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
7
Ingested recalls
0

Clearances, product code DAH

By decision year
7 clearances under product code DAH with a decision year between 1986 and 1993, 1986 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code DAH by decision year
YearClearances
19862
19882
19901
19911
19931

Applicants with the most clearances

Product code DAH
Applicants holding the most 510(k) clearances under product code DAH
ApplicantClearances
Helena Laboratories, Corp.3
Abbott Medical1
Dako Corp.1
Orion Diagnostica, Inc.1
Technicon Instruments Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code