GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL
FDA 510(k) clearance K863038 · decided 1986-09-30
Clearance details
- K-number
- K863038
- Device name
- GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL
- Applicant
- American Micro Scan
- Decision
- Substantially Equivalent
- Date received
- 1986-08-12
- Decision date
- 1986-09-30
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- LQL
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- West Sacramento, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MIC PANELS (N62160/S013) | American Micro Scan | 1985-03-05 |
| MIC PANELS (N62160/S011) | American Micro Scan | 1984-01-30 |
| MIC PANELS (N62160/S012) | American Micro Scan | 1984-01-30 |
| MIC PANELS (N62160/S010) | American Micro Scan | 1983-10-12 |
| MIC PANELS (N62160/S009) | American Micro Scan | 1983-09-28 |
| MIC PANELS (N62160/S008) | American Micro Scan | 1983-08-10 |
| MIC PANELS (N62160/S007) | American Micro Scan | 1983-02-03 |
| MIC PANELS (N62160/S006) | American Micro Scan | 1982-11-18 |