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

Immunochemical, Bence-Jones Protein

21 CFR 866.5150 / Immunology
FDA source (opens on fda.gov)

JKM is the FDA product code for Immunochemical, Bence-Jones Protein, a class II device type, regulated under 21 CFR 866.5150. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JKM
Device name
Immunochemical, Bence-Jones Protein
Regulation
21 CFR 866.5150
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
4
Ingested recalls
0

Clearances, product code JKM

By decision year
4 clearances under product code JKM with a decision year between 1998 and 2008, 1998 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code JKM by decision year
YearClearances
19981
20051
20071
20081

Applicants with the most clearances

Product code JKM
Applicants holding the most 510(k) clearances under product code JKM
ApplicantClearances
Sebia, Inc.2
Siemens Healthcare Diagnostics Inc.1
Morax1

Companies listing this code with FDA

Companies whose registered establishments list this code