RAICHEM TM HEMOGLOBIN CALIBRATOR— 510(k) K896921

Name: FDA 510(k) clearance K896921
Creator: U.S. Food and Drug Administration
Published: 1990-01-25

Substantially Equivalent

Reagents Applications, Inc.

FDA 510(k) clearance K896921 for RAICHEM TM HEMOGLOBIN CALIBRATOR, Substantially Equivalent on 1990-01-25. Applicant: Reagents Applications, Inc.. Device class: 2.

Clearance details

Applicant: Reagents Applications, Inc.
Product code: Code KRZ
Device class: Class 2
Regulation: 21 CFR 864.8165
Advisory panel: Hematology
Date received: 1989-12-11
Decision date: 1990-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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