HEMDETECT(R) TEST FOR OCCULT BLOOD IN FECES— 510(k) K936056

Name: FDA 510(k) clearance K936056
Creator: U.S. Food and Drug Administration
Published: 1995-04-05

Substantially Equivalent

Dipro Diagnostic Products GmbH

FDA 510(k) clearance K936056 for HEMDETECT(R) TEST FOR OCCULT BLOOD IN FECES, Substantially Equivalent on 1995-04-05. Applicant: Dipro Diagnostic Products GmbH. Device class: 2.

Clearance details

Applicant: Dipro Diagnostic Products GmbH
Product code: Code KHE
Device class: Class 2
Regulation: 21 CFR 864.6550
Advisory panel: Hematology
Date received: 1993-12-20
Decision date: 1995-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mamaroneck, NY, US

Download summary PDF View on FDA.gov ↗

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