QUADRA-TITER I.D.
FDA 510(k) clearance K860208 · decided 1986-03-03
Clearance details
- K-number
- K860208
- Device name
- QUADRA-TITER I.D.
- Applicant
- Microtech Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-01-22
- Decision date
- 1986-03-03
- Days to decision
- 40 days
- Clearance type
- Traditional
- Product code
- JSS
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Aurora, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MIC TEST PANELS (N50487/S015) | Microtech Medical Systems, Inc. | 1984-03-01 |
| MIC TEST PANELS (N50487/S011) | Microtech Medical Systems, Inc. | 1982-11-16 |
| MIC TEST PANELS (N50487/S012) | Microtech Medical Systems, Inc. | 1982-11-16 |
| MIC TEST PANELS (N50487/S013) | Microtech Medical Systems, Inc. | 1982-10-08 |
| MIC TEST PANELS (N50487/S010) | Microtech Medical Systems, Inc. | 1981-09-22 |
| MIC TEST PANELS (N50487/S006) | Microtech Medical Systems, Inc. | 1981-05-06 |
| MIC TEST PANELS (N50487/S008) | Microtech Medical Systems, Inc. | 1981-05-06 |
| UTI MIC TEST PANEL (N50487/S007) | Microtech Medical Systems, Inc. | 1981-05-06 |