AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U— 510(k) K982831
Substantially EquivalentOraSure Technologies, Inc.
FDA 510(k) clearance K982831 for AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U, Substantially Equivalent on 1998-11-12. Applicant: OraSure Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- OraSure Technologies, Inc.
- Product code
- Code JXM
- Device class
- Class 2
- Regulation
- 21 CFR 862.3170
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bethlehem, PA, US
Recent devices under product code JXM
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