DAH
7 FDA 510(k) clearances · Product code
47 daysmedian time to decision
260 days90th percentile
7clearances measured
FDA profile
- Official device name
- Gamma Globulin, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| TITAN GEL IMMUNOFIX-9 CAT. NO. 3051 AND 3067 (K931247) | Helena Laboratories | 1993-04-27 |
| TITAN GEL (K905149) | Helena Laboratories | 1991-01-03 |
| REP(R) IMMUNOFIX (K901805) | Helena Laboratories | 1990-06-06 |
| IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G (K884074) | Orion Diagnostica, Inc. | 1988-10-27 |
| TECHNICON DPA-1 IMMUNOGLOBULIN G (K883494) | Technicon Instruments Corp. | 1988-09-07 |
| TDX IMMUNOGLOBULIN M DIAGNOSTIC KIT (K854944) | Abbott Laboratories | 1986-08-27 |
| DAKO ITA, IMMUNOGLOBULIN M (IGM) (K862184) | Dako Corp. | 1986-08-19 |
Track DAH automatically
Every clearance here is in the API, with alerts when new ones post.