DeviceClearance

STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541— 510(k) K000399

Substantially Equivalent

OraSure 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..

Clearance details

Applicant
OraSure Technologies, Inc.
Product code
Code LCM
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Bethlehem, PA, US
Download summary PDFView on FDA.gov ↗

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