Cleared Traditional

CELL-DYN CALIBRATOR

K902892 · Unipath , Ltd. · Hematology
Sep 1990
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K902892 is an FDA 510(k) clearance for the CELL-DYN CALIBRATOR, a Calibrator For Hemoglobin And Hematocrit Measurement (Class II — Special Controls, product code KRZ), submitted by Unipath , Ltd. (Mountain View, US). The FDA issued a Cleared decision on September 10, 1990, 70 days after receiving the submission on July 2, 1990. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8165.

Submission Details

510(k) Number K902892 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 1990
Decision Date September 10, 1990
Days to Decision 70 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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