Cleared Traditional

RAICHEM TM HEMOGLOBIN CALIBRATOR

K896921 · Reagents Applications, Inc. · Hematology
Jan 1990
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K896921 is an FDA 510(k) clearance for the RAICHEM TM HEMOGLOBIN CALIBRATOR, a Calibrator For Hemoglobin And Hematocrit Measurement (Class II — Special Controls, product code KRZ), submitted by Reagents Applications, Inc. (San Diego, US). The FDA issued a Cleared decision on January 25, 1990, 45 days after receiving the submission on December 11, 1989. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8165.

Submission Details

510(k) Number K896921 FDA.gov
FDA Decision Cleared SESE
Date Received December 11, 1989
Decision Date January 25, 1990
Days to Decision 45 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code KRZ — Calibrator For Hemoglobin And Hematocrit Measurement
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.8165

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