FDA Product Code JKR: Radioimmunoassay, Calcitonin
Leading manufacturers include Diagnostic Systems Laboratories, Inc., Nichols Institute Diagnostics and Diagnostic Products Corp..
20
Total
20
Cleared
108d
Avg days
1979
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
Review times increasing: avg
266d
recently vs 99d historically
FDA 510(k) Cleared Radioimmunoassay, Calcitonin Devices (Product Code JKR)
20 devices
Cleared
Apr 24, 2026
Elecsys Calcitonin
Roche Diagnostics GmbH
Chemistry
266d
Cleared
Dec 21, 2018
ADVIA Centaur Calcitonin (CALCT) assay
Axis-Shield Diagnostics Limited
Chemistry
147d
Cleared
Dec 04, 2013
ELECSYS CALCITONIN
Roche Diagnostics
Chemistry
86d
Cleared
Aug 30, 2006
CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION)
Scantibodies Laboratory, Inc.
Chemistry
177d
Cleared
Dec 09, 2002
IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL
Diagnostic Products Corp.
Chemistry
67d
Cleared
May 21, 1997
NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT
Nichols Institute Diagnostics
Chemistry
183d
Cleared
May 06, 1996
SCANTIBODIES CALCITONIN IMMUNORADIOMETRIC ASSAY (COATED BEAD TECHNOLOGY)
Scantibodies Laboratory, Inc.
Chemistry
53d
Cleared
Nov 20, 1995
CALCITONIN IMMUNOASSAY KIT
Nichols Institute Diagnostics
Chemistry
348d
Cleared
Jan 15, 1992
DSL ULTRA-SENSITIVE CALCITONIN RIA (DSL 5200)
Diagnostic Systems Laboratories, Inc.
Chemistry
103d
Cleared
Feb 02, 1988
MODIFIED CALCITONIN RIA KIT DSL #1200
Diagnostic Systems Laboratories, Inc.
Chemistry
118d
Cleared
Jun 25, 1986
DOUBLE ANTIBODY CALCITONIN RIA KIT
Diagnostic Products Corp.
Chemistry
79d
Cleared
Nov 22, 1985
CALCITONIN RIA KIT
Diagnostic Systems Laboratories, Inc.
Chemistry
32d
Cleared
Sep 05, 1984
CALCITONIN RADIOIMMUNOASSAY KIT
Nichols Institute Diagnostics
Chemistry
43d
Cleared
Jun 22, 1982
CALCITONIN RIA TEST KIT, DLS 1200
Diagnostic Systems Laboratories, Inc.
Chemistry
14d
About Product Code JKR - Regulatory Context
510(k) Submission Activity
20 total 510(k) submissions under product code JKR since 1979, with 20 receiving FDA clearance (average review time: 108 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - JKR Product Code
Recent submissions under JKR have taken an average of 266 days to reach a decision - up from 99 days historically. Manufacturers should account for longer review timelines in current project planning.
JKR devices are reviewed by the Chemistry panel. Browse all Chemistry devices →