Cleared Traditional

CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE

K897060 · R&D Systems, Inc. · Hematology
Jan 1990
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K897060 is an FDA 510(k) clearance for the CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE, a Calibrator For Red-cell And White-cell Counting (Class II — Special Controls, product code KSA), submitted by R&D Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on January 2, 1990, 15 days after receiving the submission on December 18, 1989. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8185.

Submission Details

510(k) Number K897060 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 1989
Decision Date January 02, 1990
Days to Decision 15 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code KSA — Calibrator For Red-cell And White-cell Counting
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.8185

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