hema-screen SPECIFIC Gold— 510(k) K171484

Substantially Equivalent

Immunostics Inc.,

FDA 510(k) clearance K171484 for hema-screen SPECIFIC Gold, Substantially Equivalent on 2017-06-14. 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: 2017-05-22
Decision date: 2017-06-14
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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K170548 — InSure ONE2017-10-05
K162333 — Wondfo One Step Fecal Occult Blood (FOB) Test2017-05-14
K163554 — hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test2017-01-17
K143325 — OC-Light S FIT2015-08-20

More clearances from Immunostics Inc.,

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K163225 — AFIAS iFOB with AFIAS-502017-08-08
K102664 — HEMA SCREEN ER2011-01-28

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