LQM — Gram Negative Identification Panel Class I
FDA product code LQM covers "Gram Negative Identification Panel", a Class I medical device regulated under 21 CFR 866.2660. Submissions are reviewed by the Microbiology panel. At least 7 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LQM
- Device Class
- Class I
- Regulation Number
- 866.2660
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K923313 | roche diagnostic systems | ROCHE OXI/FERM II | April 5, 1993 |
| K925915 | biomerieux vitek | VITEK RAPID CALL-GRAM NEGATIV IDENT CARD | March 23, 1993 |
| K912897 | bd becton dickinson vacutainer systems preanalytic | SCEPTOR IDENTIFICATION SYSTEM | October 28, 1991 |
| K911429 | vitek systems | VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIED | June 24, 1991 |
| K890057 | radiometer america | SENSITITRE AUTO ID PLATE AP80 | June 9, 1989 |
| K862642 | american micro scan | GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL | September 11, 1986 |
| K851528 | pasco laboratories | PASCO GRAM NEGATIVE IDENTIFICATION SYSTEM | July 15, 1985 |