MIC PANELS
FDA premarket approval N62160/S010 · decided 1983-10-12
Approval details
- PMA number
- N62160
- Supplement
- S010
- Trade name
- MIC PANELS
- Generic name
- Panels, test, susceptibility, antimicrobial
- Applicant
- American Micro Scan
- Date received
- 1983-09-19
- Decision date
- 1983-10-12
- Days to decision
- 23 days
- Decision code
- APPR
- Product code
- LTT
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Campbell, CA
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE (K870029) | American Micro Scan | 1987-03-25 |
| CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARS (K864662) | American Micro Scan | 1987-03-25 |
| MICRODILUTION MIC PANELS (K863776) | American Micro Scan | 1987-02-02 |
| MICRODILUTION IDENTIFICATION PANELS (K864674) | American Micro Scan | 1987-01-05 |
| CHLAMYDIAE FLOURESCENT MONOCLONAL ANTIBODY TEST (K864389) | American Micro Scan | 1986-12-04 |
| GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL (K863038) | American Micro Scan | 1986-09-30 |
| GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL (K862642) | American Micro Scan | 1986-09-11 |
| ANAEROBE RAPID CHROMOGENIC ID PANEL (K862332) | American Micro Scan | 1986-08-27 |