MICRO-PLATE COTININE EIA— 510(k) K974234
Substantially EquivalentOraSure Technologies, Inc.
FDA 510(k) clearance K974234 for MICRO-PLATE COTININE EIA, Substantially Equivalent on 1998-05-14. Applicant: OraSure Technologies, Inc.. Device class: 1.
Clearance details
- Applicant
- OraSure Technologies, Inc.
- Product code
- Code MKU
- Device class
- Class 1
- Regulation
- 21 CFR 862.3220
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bethlehem, PA, US
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