LQL — Gram Positive Identification Panel Class I
FDA product code LQL covers "Gram Positive Identification Panel", a Class I medical device regulated under 21 CFR 866.2660. Submissions are reviewed by the Microbiology panel. At least 11 recent 510(k) clearances have been granted under this product code.
Classification details
- Product Code
- LQL
- Device Class
- Class I
- Regulation Number
- 866.2660
- Submission Type
- 510(k) Exempt
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K972576 | Accumed Intl | GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90 | Jan 22, 1998 |
| K961730 | Becton Dickinson Microbiology Systems | RAPID GRAM-POSITIVE ID SYSTEM | Feb 4, 1997 |
| K961968 | Bd Becton Dickinson Vacutainer Systems Preanalytic | BBLCRYSTAL GRAM-POSITIVE ID SYSTEM | Feb 4, 1997 |
| K952095 | Biomerieux Vitek | VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI) | Mar 12, 1996 |
| K925916 | Biomerieux Vitek | VITEK RAPID CALL-GRAM POSITIVE IDENTIFICATION CARD | Mar 23, 1993 |
| K910304 | Vitek Systems | RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA | Jul 26, 1991 |
| K910537 | Kev Connecticut Diagnostics | VISI-STREP | Apr 12, 1991 |
| K901559 | Analytical Products | MODIFICATION TO API UNISCEPT 20GP | Sep 10, 1990 |
| K891004 | Dms Products | RAPIDEC STAPH | Nov 9, 1989 |
| K874606 | Mct Medical | CATHRA GRAM POSITIVE SCREEN | May 6, 1988 |
| K863038 | American Micro Scan | GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL | Sep 30, 1986 |