KRY · Class II · 21 CFR 864.8175

FDA Product Code KRY: Calibrator For Platelet Counting

Leading manufacturers include Coulter Electronics, Inc., Streck Laboratories, Inc. and Technicon Instruments Corp..

8
Total
8
Cleared
132d
Avg days
1978
Since

FDA 510(k) Cleared Calibrator For Platelet Counting Devices (Product Code KRY)

8 devices
1–8 of 8
Cleared May 20, 1987
S-CAL HEMATOLOGY CALIBRATOR
K862122
Coulter Electronics, Inc.
Hematology · 351d
Cleared Jul 09, 1985
LASER PLATELETCAL/MULTIPLE
K852016
R&D Systems, Inc.
Hematology · 61d
Cleared Jan 07, 1985
COULTER MEAN PLATELET VOLUME CALIBRATOR
K843910
Coulter Electronics, Inc.
Hematology · 96d
Cleared Apr 04, 1984
S-CAL HEMATOLOGY CALIBRATOR
K840794
Coulter Electronics, Inc.
Hematology · 41d
Cleared Oct 10, 1978
TEKNI-CAL
K781601
Streck Laboratories, Inc.
Chemistry · 22d
Cleared Aug 14, 1978
PC-CALIBRATOR
K781133
Streck Laboratories, Inc.
Hematology · 39d
Cleared Jan 30, 1978
TQC CALIBRATION REFERENCE FOR PLATELETS
K770143
Technicon Instruments Corp.
Hematology · 371d

About Product Code KRY - Regulatory Context