HEMOGLOBIN DETERMINATION TEST KIT HGB S-100 & 12— 510(k) K874429

Name: FDA 510(k) clearance K874429
Creator: U.S. Food and Drug Administration
Published: 1988-02-04

Substantially Equivalent

Hf Scientific, Inc.

FDA 510(k) clearance K874429 for HEMOGLOBIN DETERMINATION TEST KIT HGB S-100 & 12, Substantially Equivalent on 1988-02-04. Applicant: Hf Scientific, Inc.. Device class: 2.

Clearance details

Applicant: Hf Scientific, Inc.
Product code: Code GIQ
Device class: Class 2
Regulation: 21 CFR 864.7415
Advisory panel: Hematology
Date received: 1987-10-28
Decision date: 1988-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ft. Myers, FL, US

Download summary PDF View on FDA.gov ↗

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