INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX— 510(k) K011057

Name: FDA 510(k) clearance K011057
Creator: U.S. Food and Drug Administration
Published: 2001-06-06

Substantially Equivalent

OraSure Technologies, Inc.

FDA 510(k) clearance K011057 for INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX, Substantially Equivalent on 2001-06-06. Applicant: OraSure Technologies, Inc.. Device class: 2.

Clearance details

Applicant: OraSure Technologies, Inc.
Product code: Code PJD
Device class: Class 2
Regulation: 21 CFR 862.1675
Advisory panel: Clinical Chemistry
Date received: 2001-04-06
Decision date: 2001-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethlehem, PA, US

Download summary PDF View on FDA.gov ↗

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