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

Radioimmunoassay, Calcitonin

21 CFR 862.1140 / Clinical Chemistry
FDA source (opens on fda.gov)

JKR is the FDA product code for Radioimmunoassay, Calcitonin, a class II device type, regulated under 21 CFR 862.1140. As of , FDA records hold 20 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
JKR
Device name
Radioimmunoassay, Calcitonin
Regulation
21 CFR 862.1140
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
20
Ingested recalls
1

Clearances, product code JKR

By decision year
20 clearances under product code JKR with a decision year between 1979 and 2026, 1995 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code JKR by decision year
YearClearances
19791
19821
19841
19851
19861
19871
19881
19911
19921
19952
19961
19971
19981
19991
20021
20061
20131
20181
20261

Applicants with the most clearances

Product code JKR
Applicants holding the most 510(k) clearances under product code JKR
ApplicantClearances
Diagnostic Systems Laboratories, Inc.4
Nichols Institute Diagnostics3
Siemens Healthcare Diagnostics Inc.2
Roche Diagnostics GmbH2
Scantibodies Laboratory Inc.2
Axis-Shield Diagnostics, Ltd.1
Cambridge Nuclear Radiopharmaceutical1
Cis-Us, Inc.1
Endocrine Associates, Inc.1
Kmi Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code