JCA · Class II · 21 CFR 864.6100

FDA Product Code JCA: Device, Bleeding Time

Leading manufacturers include International Technidyne Corp., General Diagnostics and Ulster Scientific, Inc..

7
Total
7
Cleared
64d
Avg days
1977
Since

FDA 510(k) Cleared Device, Bleeding Time Devices (Product Code JCA)

7 devices
1–7 of 7
Cleared Aug 09, 1991
SIMPLATE PEDIATRIC
K911745
Organon Teknika Corp.
Hematology · 113d
Cleared Jul 17, 1991
SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION
K911996
International Technidyne Corp.
Hematology · 86d
Cleared Jun 10, 1987
Q.I.C. BLEEDING TIME DEVICE
K871318
Helena Laboratories
Hematology · 68d
Cleared Mar 01, 1985
SURGICUTT - BLEEDING TIME DEVICE
K850542
International Technidyne Corp.
Hematology · 18d
Cleared Mar 17, 1983
BLEEDING TIME DEVICE DISPOSABLE
K830645
American Dade
Hematology · 16d
Cleared Oct 10, 1980
AUTOLET
K801815
Ulster Scientific, Inc.
Hematology · 72d
Cleared Mar 01, 1977
SIMPLATE
K761250
General Diagnostics
Hematology · 78d

About Product Code JCA - Regulatory Context