STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION
FDA 510(k) clearance K940048 · decided 1996-03-19
Clearance details
- K-number
- K940048
- Device name
- STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION
- Applicant
- Solarcare Technologies Corp,Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-01-05
- Decision date
- 1996-03-19
- Days to decision
- 804 days
- Clearance type
- Traditional
- Product code
- DLJ
- Device class
- 2
- Regulation number
- 862.3200
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Bethlehem, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.