Cleared Traditional

CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION)

K060578 · Scantibodies Laboratory, Inc. · Chemistry
Aug 2006
Decision
177d
Days
Class 2
Risk

About This 510(k) Submission

K060578 is an FDA 510(k) clearance for the CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION), a Radioimmunoassay, Calcitonin (Class II — Special Controls, product code JKR), submitted by Scantibodies Laboratory, Inc. (Santee, US). The FDA issued a Cleared decision on August 30, 2006, 177 days after receiving the submission on March 6, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1140.

Submission Details

510(k) Number K060578 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 2006
Decision Date August 30, 2006
Days to Decision 177 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
IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL
K023304 · Diagnostic Products Corp. · Dec 2002
CALCITONIN
K990073 · Kmi Diagnostics, Inc. · May 1999
SANGUI BIOTECH, INC. CALCITONIN ELISA KIT
K982491 · Sangui Biotech, Inc. · Sep 1998
NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT
K964635 · Nichols Institute Diagnostics · May 1997

More from Scantibodies Laboratory, Inc.

View all
MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY KIT, MODEL 3KG002
K060420 · CEW · Mar 2006
MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT
K060348 · CEW · Feb 2006
TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013
K051888 · CEW · Oct 2005
WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL 3KG014
K051810 · CEW · Sep 2005
WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILUMINOMETRIC ASSAY (ICMA), MODEL 3KG002
K051141 · CEW · Jul 2005