JBR · Class II · 21 CFR 864.7525

FDA Product Code JBR: Test, Heparin Neutralization

Leading manufacturers include Bay Area Hema. Onco. Clinic. & Res. L, Probe-Tek, Inc. and Baxter Diagnostics, Inc..

3
Total
3
Cleared
76d
Avg days
1977
Since

FDA 510(k) Cleared Test, Heparin Neutralization Devices (Product Code JBR)

3 devices
1–3 of 3
Cleared Jan 11, 1993
DADE HEPZYME
K925452
Baxter Diagnostics, Inc.
Hematology · 75d
Cleared Jan 05, 1988
PT PRO-CLOT
K874373
Probe-Tek, Inc.
Hematology · 71d
Cleared Jul 11, 1977
THROMBO SCREEN QUANTITATIVE HEPARIN ASSA
K770722
Bay Area Hema. Onco. Clinic. & Res. L
Hematology · 83d

About Product Code JBR - Regulatory Context