Panels › Microbiology › Product code GMT · Class 2
Antigens, Ha, Treponema Pallidum
Regulation 866.3830
0510(k)s in 12 months (9 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in GMT
| Company | 510(k)s | Recalls |
|---|---|---|
| Olympus Corp. | 2 | 0 |
| Behring Diagnostics, Inc. | 1 | 0 |
| Difco Laboratories, Inc. | 1 | 0 |
| Fujirebio America, Inc. | 1 | 0 |
| Fujirebio Diagnostics,Inc. | 1 | 0 |
| Gamma Biologicals, Inc. | 1 | 0 |
| Scimedx Tekfile Services | 1 | 0 |
| Volu Sol Medical Industries | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 13, 1997 | K971502 | SERODIA TP-PA Scimedx Tekfile Services | GMT |
| Jul 24, 1991 | K911640 | OLYMPUS PK TP(TM) SYSTEM, MODIFICATION Olympus Corp. | GMT |
| May 7, 1991 | K911266 | MODIFIED PK TP CONTROL Olympus Corp. | GMT |
| May 6, 1991 | K905038 | OLYMPUS PK-TP ABSORBENT KIT Fujirebio America, Inc. | GMT |
| May 15, 1990 | K896410 | CELLOGNOST SYPHILIS H Behring Diagnostics, Inc. | GMT |
| Nov 17, 1989 | K893124 | OLYMPUS PK(TM) TP Fujirebio Diagnostics,Inc. | GMT |
| Nov 13, 1979 | K791897 | BACTO-HATTS Difco Laboratories, Inc. | GMT |
| Sep 24, 1979 | K791457 | AGGLUTINOTEST-SYPHILIS Volu Sol Medical Industries | GMT |
| Aug 3, 1976 | K760098 | REAGENT, VDRL Gamma Biologicals, Inc. | GMT |
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