COLORECTAL CANCER RISK DETECTOR (TM)— 510(k) K874180

Name: FDA 510(k) clearance K874180
Creator: U.S. Food and Drug Administration
Published: 1988-09-30

Substantially Equivalent

Pearce Clinical Laboratories, Inc.

FDA 510(k) clearance K874180 for COLORECTAL CANCER RISK DETECTOR (TM), Substantially Equivalent on 1988-09-30. Applicant: Pearce Clinical Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Pearce Clinical Laboratories, Inc.
Product code: Code KHE
Device class: Class 2
Regulation: 21 CFR 864.6550
Advisory panel: Hematology
Date received: 1987-10-14
Decision date: 1988-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Conroe, TX, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.