LQL
11 FDA 510(k) clearances · Product code
183 daysmedian time to decision
277 days90th percentile
11clearances measured
FDA profile
- Official device name
- Gram Positive Identification Panel
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Medical specialty
- Microbiology
- Adverse events (MAUDE)
- 2015: 18 · 2016: 35 · 2017: 89 · 2018: 70 · 2025: 23 · 2026: 34
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90 (K972576) | Accumed Intl., Inc. | 1998-01-22 |
| RAPID GRAM-POSITIVE ID SYSTEM (K961730) | Becton Dickinson Microbiology Systems | 1997-02-04 |
| BBLCRYSTAL GRAM-POSITIVE ID SYSTEM (K961968) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1997-02-04 |
| VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI) (K952095) | Biomerieux Vitek, Inc. | 1996-03-12 |
| VITEK RAPID CALL-GRAM POSITIVE IDENTIFICATION CARD (K925916) | Biomerieux Vitek, Inc. | 1993-03-23 |
| RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA (K910304) | Vitek Systems, Inc. | 1991-07-26 |
| VISI-STREP (K910537) | Kev Connecticut Diagnostics, Inc. | 1991-04-12 |
| MODIFICATION TO API UNISCEPT 20GP (K901559) | Analytical Products, Inc. | 1990-09-10 |
| RAPIDEC STAPH (K891004) | Dms Products, Inc. | 1989-11-09 |
| CATHRA GRAM POSITIVE SCREEN (K874606) | Mct Medical, Inc. | 1988-05-06 |
| GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL (K863038) | American Micro Scan | 1986-09-30 |
Track LQL automatically
Every clearance here is in the API, with alerts when new ones post.