FDA product code DAH: Gamma Globulin, Antigen, Antiserum, Control
DAH is the FDA product code for gamma globulin, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Immunology panel. FDA has cleared 7 510(k) submissions under DAH, from 5 different applicants. The average 510(k) review took 75 days (median 47).
Classification
| Field | Value |
|---|---|
| Device name | Gamma Globulin, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5510 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DAH clearance
Top DAH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Helena Laboratories | 3 | 1993-04-27 |
| Orion Diagnostica, Inc. | 1 | 1988-10-27 |
| Technicon Instruments Corp. | 1 | 1988-09-07 |
| Abbott Laboratories | 1 | 1986-08-27 |
| Dako Corp. | 1 | 1986-08-19 |
Most recent DAH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K931247 | Helena Laboratories | TITAN GEL IMMUNOFIX-9 CAT. NO. 3051 AND 3067 | 1993-04-27 | 47 |
| K905149 | Helena Laboratories | TITAN GEL | 1991-01-03 | 49 |
| K901805 | Helena Laboratories | REP(R) IMMUNOFIX | 1990-06-06 | 47 |
| K884074 | Orion Diagnostica, Inc. | IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G | 1988-10-27 | 30 |
| K883494 | Technicon Instruments Corp. | TECHNICON DPA-1 IMMUNOGLOBULIN G | 1988-09-07 | 22 |
Recalls for DAH devices
openFDA lists no recalls for product code DAH.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- J1460 — Injection, gamma globulin, intramuscular, 1 cc
- J1560 — Injection, gamma globulin, intramuscular, over 10 cc
Frequently asked questions
What is FDA product code DAH?
DAH is the FDA product code for gamma globulin, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Immunology panel.
What device class is DAH?
Class II, regulation 21 CFR 866.5510. Typical premarket route: 510(k).
How long does a 510(k) take for product code DAH?
Across 7 cleared submissions the average was 75 days from receipt to decision (median 47).
Which companies have the most DAH clearances?
Helena Laboratories (3); Orion Diagnostica, Inc. (1); Technicon Instruments Corp. (1); Abbott Laboratories (1); Dako Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DAH
- Run a recall and safety report across every DAH manufacturer
- Watch product code DAH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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