STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541— 510(k) K000399
Substantially EquivalentOraSure Technologies, Inc.
FDA 510(k) clearance K000399 for STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541, Substantially Equivalent on 2000-05-15. Applicant: OraSure Technologies, Inc.. Device class: Unclassified.
Clearance details
- Applicant
- OraSure Technologies, Inc.
- Product code
- Code LCM
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bethlehem, PA, US
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