MONOHAEM (FECAL OCCULT BLOOD TEST)— 510(k) K901064

Name: FDA 510(k) clearance K901064
Creator: U.S. Food and Drug Administration
Published: 1990-11-05

Substantially Equivalent

Silenus Laboratories Proprietary , Ltd.

FDA 510(k) clearance K901064 for MONOHAEM (FECAL OCCULT BLOOD TEST), Substantially Equivalent on 1990-11-05. Applicant: Silenus Laboratories Proprietary , Ltd.. Device class: 2.

Clearance details

Applicant: Silenus Laboratories Proprietary , Ltd.
Product code: Code KHE
Device class: Class 2
Regulation: 21 CFR 864.6550
Advisory panel: Hematology
Date received: 1990-03-07
Decision date: 1990-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, DE, 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.