PASCO MIC AND MIC/ID PANELS
FDA 510(k) clearance K935805 · decided 1994-06-13
Clearance details
- K-number
- K935805
- Device name
- PASCO MIC AND MIC/ID PANELS
- Applicant
- Pasco Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-12-02
- Decision date
- 1994-06-13
- Days to decision
- 193 days
- Clearance type
- Traditional
- Product code
- JTT
- Device class
- 2
- Regulation number
- 866.1640
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Wheat Ridge, CO, 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.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MIC ANTIBIOTIC TEST PANELS (N50494/S006) | Pasco Laboratories, Inc. | 1983-11-02 |
| MIC ANTIBIOTIC TEST PANELS (N50494/S011) | Pasco Laboratories, Inc. | 1983-07-25 |
| MIC ANTIBIOTIC TEST PANELS (N50494/S010) | Pasco Laboratories, Inc. | 1983-07-08 |
| MIC ANTIBIOTIC TEST PANELS (N50494/S008) | Pasco Laboratories, Inc. | 1982-12-22 |
| MIC ANTIBIOTIC TEST PANELS (N50494/S009) | Pasco Laboratories, Inc. | 1982-12-01 |
| MIC ANTIBIOTIC TEST PANELS (N50494/S007) | Pasco Laboratories, Inc. | 1982-09-03 |
| MIC ANTIBIOTIC TEST PANELS (N50494/S005) | Pasco Laboratories, Inc. | 1982-06-30 |
| MIC ANTIBIOTIC TEST PANELS (N50494/S004) | Pasco Laboratories, Inc. | 1982-03-12 |