AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U— 510(k) K982759
Substantially EquivalentOraSure Technologies, Inc.
FDA 510(k) clearance K982759 for AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U, Substantially Equivalent on 1998-11-20. Applicant: OraSure Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- OraSure Technologies, Inc.
- Product code
- Code DIO
- Device class
- Class 2
- Regulation
- 21 CFR 862.3250
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bethlehem, PA, US
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