Panels › Microbiology › Product code GTN · Class 1
Antisera, Fluorescent, All Types, Staphylococcus Spp.
Regulation 866.3700
0510(k)s in 12 months (4 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in GTN
| Company | 510(k)s | Recalls |
|---|---|---|
| Oxoid U.S.A., Inc. | 2 | 0 |
| Volu Sol Medical Industries | 1 | 0 |
| Wellcome Diagnostics | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 4, 1986 | K855236 | DIAGNOSTIC REAGENT TST-RPLA Oxoid U.S.A., Inc. | GTN |
| Nov 4, 1986 | K855233 | DIAGNOSTIC REAGENT SET-RPLA Oxoid U.S.A., Inc. | GTN |
| May 22, 1985 | K851949 | STAPHAUREX ZL30 Wellcome Diagnostics | GTN |
| Sep 24, 1979 | K791453 | AGGLUTINOTEST-STAPHYLOLISIN Volu Sol Medical Industries | GTN |
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