KSA · Class II · 21 CFR 864.8185

FDA Product Code KSA: Calibrator For Red-cell And White-cell Counting

Leading manufacturers include R&D Systems, Inc., Coulter Electronics, Inc. and American Dade.

8
Total
8
Cleared
73d
Avg days
1982
Since

FDA 510(k) Cleared Calibrator For Red-cell And White-cell Counting Devices (Product Code KSA)

8 devices
1–8 of 8
Cleared Dec 15, 1994
SCS-1000 (SYSMEX CALIBRATOR SYSTEM)
K943268
Streck Laboratories, Inc.
Hematology · 161d
Cleared Jan 02, 1990
CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE
K897060
R&D Systems, Inc.
Hematology · 15d
Cleared May 02, 1988
TECH-CAL(TM)/MULTIPLE
K881161
R&D Systems, Inc.
Hematology · 45d
Cleared Feb 06, 1987
H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS
K864664
Technicon Instruments Corp.
Hematology · 70d
Cleared Feb 13, 1986
CBC-CAL/MULTIPLE
K854823
R&D Systems, Inc.
Hematology · 72d
Cleared Feb 22, 1982
HEMOTOLOGY CALIBRATOR
K813530
American Dade
Hematology · 67d
Cleared Feb 04, 1982
HEMATOLOGY CALIBRATOR S-CAL
K813375
Coulter Electronics, Inc.
Hematology · 65d

About Product Code KSA - Regulatory Context