Product code JBR— Hematology

DADE HEPZYME

Classification name: Test, Heparin Neutralization
Device class: Class 2
Regulation: 21 CFR 864.7525
Advisory panel: Hematology
Total cleared: 3
First cleared: 1977-07-11
Most recent: 1993-01-11

Market context for product code JBR

FDA has cleared 3 devices under product code JBR between 1977 and 1993, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

19931 clearance
19881 clearance
19771 clearance

Top applicants under product code JBR

Probe-Tek, Inc.1 clearance
Bay Area Hema. Onco. Clinic. & Res. L1 clearance
Baxter Diagnostics, Inc.1 clearance

Recent clearances under product code JBR

K925452 — DADE HEPZYMEBaxter Diagnostics, Inc.·1993-01-11
K874373 — PT PRO-CLOTProbe-Tek, Inc.·1988-01-05
K770722 — THROMBO SCREEN QUANTITATIVE HEPARIN ASSABay Area Hema. Onco. Clinic. & Res. L·1977-07-11

Data sourced from openFDA. This site is unofficial and independent of the FDA.