AUTO-LYTE PCP EIA, MODEL #1254U— 510(k) K982801
Substantially EquivalentOraSure Technologies, Inc.
FDA 510(k) clearance K982801 for AUTO-LYTE PCP EIA, MODEL #1254U, Substantially Equivalent on 1998-11-04. 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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