Panels › Microbiology › Product code GSB · Class 1
Antigens, Cf, All, Mycoplasma Spp.
Regulation 866.3375
0510(k)s in 12 months (5 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in GSB
| Company | 510(k)s | Recalls |
|---|---|---|
| Hillcrest Biologicals | 1 | 0 |
| Institute Virion , Ltd. | 1 | 0 |
| Microbix Biosystems, Inc. | 1 | 0 |
| Miles Laboratories, Inc. | 1 | 0 |
| Orion Diagnostica, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 1, 1985 | K852933 | MYCOPLASMA SPP SEROLOGICAL REAGENTS Microbix Biosystems, Inc., CA | GSB |
| Oct 25, 1984 | K843664 | MYCOPLASMA PNEUMONIAE Institute Virion , Ltd. | GSB |
| Feb 27, 1984 | K834338 | MYCOPLASMA PNEUMONIAE CF ANTIGEN Hillcrest Biologicals | GSB |
| Sep 20, 1983 | K832132 | SERA-TEK MYCOPLASMA ANTIBODY TEST Miles Laboratories, Inc. | GSB |
| Dec 31, 1980 | K802934 | MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL Orion Diagnostica, Inc. | GSB |
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