Panels › Microbiology › Product code GSA · Class 1
Antisera, All Mycoplasma Spp.
Regulation 866.3375
0510(k)s in 12 months (6 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in GSA
| Company | 510(k)s | Recalls |
|---|---|---|
| Medical Diagnostic Technologies, Inc. | 2 | 0 |
| Intl. Mycoplasma/Mdc Assoc. | 1 | 0 |
| Meridian Diagnostics, Inc. | 1 | 0 |
| Seradyn, Inc. | 1 | 0 |
| Shared Systems, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 17, 1995 | K950073 | MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYSTEM Shared Systems, Inc. | GSA |
| Jun 24, 1991 | K910833 | COLOR VUE TM- MYCOPLASMA PNEUMONIAE Seradyn, Inc. | GSA |
| Jan 30, 1991 | K905493 | MERISTAR-MP Meridian Diagnostics, Inc. | GSA |
| Dec 21, 1990 | K903958 | SEROFAST Intl. Mycoplasma/Mdc Assoc. | GSA |
| Oct 25, 1988 | K883083 | MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM Medical Diagnostic Technologies, Inc. | GSA |
| Sep 3, 1986 | K862630 | MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM Medical Diagnostic Technologies, Inc. | GSA |
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