510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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JBRClass II

Test, Heparin Neutralization

21 CFR 864.7525 / Hematology
FDA source (opens on fda.gov)

JBR is the FDA product code for Test, Heparin Neutralization, a class II device type, regulated under 21 CFR 864.7525. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JBR
Device name
Test, Heparin Neutralization
Regulation
21 CFR 864.7525
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
3
Ingested recalls
0

Clearances, product code JBR

By decision year
3 clearances under product code JBR with a decision year between 1977 and 1993, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code JBR by decision year
YearClearances
19771
19881
19931

Applicants with the most clearances

Product code JBR
Applicants holding the most 510(k) clearances under product code JBR
ApplicantClearances
Baxter Diagnostics, Inc.1
Bay Area Hema. Onco. Clinic. & Res. L1
Probe-Tek, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code