!NSURE FECAL OCCULT BLOOD TEST— 510(k) K002457

Substantially Equivalent

Enterix, Inc.

FDA 510(k) clearance K002457 for !NSURE FECAL OCCULT BLOOD TEST, Substantially Equivalent on 2001-01-12. Applicant: Enterix, Inc.. Device class: 2.

Clearance details

Applicant: Enterix, Inc.
Product code: Code KHE
Device class: Class 2
Regulation: 21 CFR 864.6550
Advisory panel: Hematology
Date received: 2000-08-10
Decision date: 2001-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Falmouth,, ME, US

Download summary PDF View on FDA.gov ↗

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More clearances from Enterix, Inc.

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