STC DIAGNOSTICS AUTO-LYTE(R) METHAQUALONE EIA
FDA 510(k) clearance K950308 · decided 1995-04-14
Clearance details
- K-number
- K950308
- Device name
- STC DIAGNOSTICS AUTO-LYTE(R) METHAQUALONE EIA
- Applicant
- Solarcare Technologies Corp,Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-01-25
- Decision date
- 1995-04-14
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- JXS
- Device class
- 1
- Regulation number
- 874.3540
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Bethlehem, PA, 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 |
|---|---|---|
| MICRO WORKTABLE (K822371) | Treace Medical, Inc. | 1982-09-09 |
Recalls involving this device
No recalls on record reference this clearance.