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

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..

Clearance details

Applicant: Silenus Laboratories Proprietary , Ltd.
Product code: Code KHE
Advisory panel: Hematology
Date received: 1990-03-07
Decision date: 1990-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, DE, US

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