Cleared Traditional

K990073: CALCITONIN

K990073 · Kmi Diagnostics, Inc. · Chemistry
May 1999
Decision
120d
Days
Class 2
Risk

K990073 is an FDA 510(k) clearance for the CALCITONIN, a Radioimmunoassay, Calcitonin (Class II — Special Controls, product code JKR), submitted by Kmi Diagnostics, Inc. (Osceola, US). The FDA issued a Cleared decision on May 11, 1999, 120 days after receiving the submission on January 11, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1140.

Submission Details

510(k) Number K990073 FDA.gov
FDA Decision Cleared SESE
Date Received January 11, 1999
Decision Date May 11, 1999
Days to Decision 120 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JKR — Radioimmunoassay, Calcitonin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1140

Similar Devices — JKR Radioimmunoassay, Calcitonin

All 18
ADVIA Centaur Calcitonin (CALCT) assay
K182012 · Axis-Shield Diagnostics Limited · Dec 2018
ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 3
K132828 · Roche Diagnostics · Dec 2013
CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION)
K060578 · Scantibodies Laboratory, Inc. · Aug 2006
IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL
K023304 · Diagnostic Products Corp. · Dec 2002
SANGUI BIOTECH, INC. CALCITONIN ELISA KIT
K982491 · Sangui Biotech, Inc. · Sep 1998
NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT
K964635 · Nichols Institute Diagnostics · May 1997