JPJ · Class II · 21 CFR 864.5300

FDA Product Code JPJ: Red-cell Indices, Calculated

Leading manufacturers include J.T. Baker Chemical Co., Hycel, Inc. and Bd Becton Dickinson Vacutainer Systems Preanalytic.

3
Total
3
Cleared
37d
Avg days
1977
Since

FDA 510(k) Cleared Red-cell Indices, Calculated Devices (Product Code JPJ)

3 devices
1–3 of 3
Cleared Nov 02, 1990
QBC SYSTEM MCHC
K904675
Bd Becton Dickinson Vacutainer Systems Preanalytic
Hematology · 21d
Cleared Jul 27, 1978
ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER
K780946
Hycel, Inc.
Hematology · 48d
Cleared Feb 01, 1977
JTB 700 HEMATOLOGY ANALYZER
K761304
J.T. Baker Chemical Co.
Hematology · 41d

About Product Code JPJ - Regulatory Context