Panels › Microbiology › Product code LQL · Class 1
Gram Positive Identification Panel
Regulation 866.2660
0510(k)s in 12 months (11 all time)
1recalls in 12 months (7 all time)
2recalls that name a 510(k)
Top companies in LQL
| Company | 510(k)s | Recalls |
|---|---|---|
| BioMerieux SA | 0 | 6 |
| Biomerieux Vitek, Inc. | 2 | 0 |
| Accumed Intl., Inc. | 1 | 0 |
| American Micro Scan | 1 | 0 |
| Analytical Products, Inc. | 1 | 0 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 0 |
| Becton Dickinson Microbiology Systems | 1 | 0 |
| Dms Products, Inc. | 1 | 0 |
| Kev Connecticut Diagnostics, Inc. | 1 | 0 |
| Mct Medical, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 22, 1998 | K972576 | GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90 Accumed Intl., Inc. | LQL |
| Feb 4, 1997 | K961968 | BBLCRYSTAL GRAM-POSITIVE ID SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic | LQL |
| Feb 4, 1997 | K961730 | RAPID GRAM-POSITIVE ID SYSTEM Becton Dickinson Microbiology Systems | LQL |
| Mar 12, 1996 | K952095 | VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI) Biomerieux Vitek, Inc. | LQL |
| Mar 23, 1993 | K925916 | VITEK RAPID CALL-GRAM POSITIVE IDENTIFICATION CARD Biomerieux Vitek, Inc. | LQL |
| Jul 26, 1991 | K910304 | RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA Vitek Systems, Inc. | LQL |
| Apr 12, 1991 | K910537 | VISI-STREP Kev Connecticut Diagnostics, Inc. | LQL |
| Sep 10, 1990 | K901559 | MODIFICATION TO API UNISCEPT 20GP Analytical Products, Inc. | LQL |
| Nov 9, 1989 | K891004 | RAPIDEC STAPH Dms Products, Inc. | LQL |
| May 6, 1988 | K874606 | CATHRA GRAM POSITIVE SCREEN Mct Medical, Inc. | LQL |
| Sep 30, 1986 | K863038 | GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL American Micro Scan | LQL |
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