HEMA SCREEN ER— 510(k) K102664

Substantially Equivalent

Immunostics Inc.,

FDA 510(k) clearance K102664 for HEMA SCREEN ER, Substantially Equivalent on 2011-01-28. Applicant: Immunostics Inc.,. Device class: 2.

Clearance details

Applicant: Immunostics Inc.,
Product code: Code KHE
Device class: Class 2
Regulation: 21 CFR 864.6550
Advisory panel: Hematology
Date received: 2010-09-15
Decision date: 2011-01-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Ocean, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KHE

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K163554 — hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test2017-01-17

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