STC DIAGNOSTICS AUTO-LYTE URINARY LEUKOCYTE ESTERASE ASSAY— 510(k) K954156
Substantially EquivalentSolarcare Technologies Corp,Inc.
FDA 510(k) clearance K954156 for STC DIAGNOSTICS AUTO-LYTE URINARY LEUKOCYTE ESTERASE ASSAY, Substantially Equivalent on 1996-07-22. Applicant: Solarcare Technologies Corp,Inc.. Device class: 1.
Clearance details
- Applicant
- Solarcare Technologies Corp,Inc.
- Product code
- Code KQO
- Device class
- Class 1
- Regulation
- 21 CFR 862.2900
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bethlehem, PA, US
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More clearances from Solarcare Technologies Corp,Inc.
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