CALIBRATOR FOR HEMOGLOBIN & HEMOCRIT— 510(k) K822327

Name: FDA 510(k) clearance K822327
Creator: U.S. Food and Drug Administration
Published: 1982-11-16

Substantially Equivalent

Interscience, Inc.

FDA 510(k) clearance K822327 for CALIBRATOR FOR HEMOGLOBIN & HEMOCRIT, Substantially Equivalent on 1982-11-16. Applicant: Interscience, Inc.. Device class: 2.

Clearance details

Applicant: Interscience, Inc.
Product code: Code KRZ
Device class: Class 2
Regulation: 21 CFR 864.8165
Advisory panel: Hematology
Date received: 1982-08-03
Decision date: 1982-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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