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

Antithrombin Iii, Two Stage Clotting Time Assay

21 CFR 864.7060 / Hematology
FDA source (opens on fda.gov)

JPE is the FDA product code for Antithrombin Iii, Two Stage Clotting Time Assay, a class II device type, regulated under 21 CFR 864.7060. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
JPE
Device name
Antithrombin Iii, Two Stage Clotting Time Assay
Regulation
21 CFR 864.7060
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
1
Ingested recalls
0

Clearances, product code JPE

By decision year
1 clearance under product code JPE with a decision year between 1994 and 1994, 1994 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code JPE by decision year
YearClearances
19941

Applicants with the most clearances

Product code JPE
Applicants holding the most 510(k) clearances under product code JPE
ApplicantClearances
Behring Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code