POS COMBO PANEL
FDA 510(k) clearance K844086 · decided 1984-11-13
Clearance details
- K-number
- K844086
- Device name
- POS COMBO PANEL
- Applicant
- American Micro Scan
- Decision
- Substantially Equivalent
- Date received
- 1984-10-22
- Decision date
- 1984-11-13
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- JTO
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Sacramento, CA, US
- Third-party review
- No
- Expedited review
- No
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| IDS RAPID CB PLUS SYSTEM (K962966) | Innovative Diagnostic Systems, Inc. | 1996-10-08 |
| COLISCREEN (K961191) | Hardy Diagnostics | 1996-06-17 |
| M. CAT BUTYRATE DISK (K960996) | Hardy Diagnostics | 1996-04-18 |
| GIBSON ID-M. CAT. (K955826) | Gibson Laboratories, Inc. | 1996-02-29 |
| DRYSLIDE CARTARRHALIS (K954783) | Difco Laboratories, Inc. | 1996-02-06 |
| LYFO(TM) DIFFERIENTAL DISK-PYR (K954812) | Microbiologics, Inc. | 1995-12-20 |
| GIBSON ID A.E. TEST (K953247) | Gibson Laboratories, Inc. | 1995-11-20 |
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 |