Cleared Traditional

CBC-CAL/MULTIPLE

K854823 · R&D Systems, Inc. · Hematology
Feb 1986
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K854823 is an FDA 510(k) clearance for the CBC-CAL/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 February 13, 1986, 72 days after receiving the submission on December 3, 1985. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8185.

Submission Details

510(k) Number K854823 FDA.gov
FDA Decision Cleared SESE
Date Received December 03, 1985
Decision Date February 13, 1986
Days to Decision 72 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

Similar Devices — KSA Calibrator For Red-cell And White-cell Counting

All 7
SCS-1000 (SYSMEX CALIBRATOR SYSTEM)
K943268 · Streck Laboratories, Inc. · Dec 1994
CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE
K897060 · R&D Systems, Inc. · Jan 1990
TECH-CAL(TM)/MULTIPLE
K881161 · R&D Systems, Inc. · May 1988
H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS
K864664 · Technicon Instruments Corp. · Feb 1987
TRI-COUNT CALIBRATOR
K844708 · Hematology Marketing Assoc. · Mar 1985
HEMOTOLOGY CALIBRATOR
K813530 · American Dade · Feb 1982