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

Radioimmunoassay, C-Peptides Of Proinsulin

21 CFR 862.1135 / Clinical Chemistry
FDA source (opens on fda.gov)

JKD is the FDA product code for Radioimmunoassay, C-Peptides Of Proinsulin, a class I device type, regulated under 21 CFR 862.1135. As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and 5 recalls.

Classification record

Product code
JKD
Device name
Radioimmunoassay, C-Peptides Of Proinsulin
Regulation
21 CFR 862.1135
Device class
Class I
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
10
Ingested recalls
5

Clearances, product code JKD

By decision year
10 clearances under product code JKD with a decision year between 1981 and 1996, 1981 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code JKD by decision year
YearClearances
19813
19821
19842
19851
19901
19951
19961

Applicants with the most clearances

Product code JKD
Applicants holding the most 510(k) clearances under product code JKD
ApplicantClearances
Siemens Healthcare Diagnostics Inc.2
Calbiochem-Behring Corp.1
Diagnostic Systems Laboratories, Inc.1
Immunex Radiochemical Diagnostics1
Immuno Nuclear Corp.1
Institut National des Radioelements1
Mallinckrodt Critical Care1
Serono Diagnostics, Inc.1
Tosoh Medics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 34 companies shown, in name order