Panels › Immunology › Product code DAH · Class 2
Gamma Globulin, Antigen, Antiserum, Control
Regulation 866.5510
0510(k)s in 12 months (7 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in DAH
| Company | 510(k)s | Recalls |
|---|---|---|
| Helena Laboratories | 3 | 0 |
| Abbott Laboratories | 1 | 0 |
| Dako Corp. | 1 | 0 |
| Orion Diagnostica, Inc. | 1 | 0 |
| Technicon Instruments Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 27, 1993 | K931247 | TITAN GEL IMMUNOFIX-9 CAT. NO. 3051 AND 3067 Helena Laboratories | DAH |
| Jan 3, 1991 | K905149 | TITAN GEL Helena Laboratories | DAH |
| Jun 6, 1990 | K901805 | REP(R) IMMUNOFIX Helena Laboratories | DAH |
| Oct 27, 1988 | K884074 | IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G Orion Diagnostica, Inc., FI | DAH |
| Sep 7, 1988 | K883494 | TECHNICON DPA-1 IMMUNOGLOBULIN G Technicon Instruments Corp. | DAH |
| Aug 27, 1986 | K854944 | TDX IMMUNOGLOBULIN M DIAGNOSTIC KIT Abbott Laboratories | DAH |
| Aug 19, 1986 | K862184 | DAKO ITA, IMMUNOGLOBULIN M (IGM) Dako Corp. | DAH |
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