Cleared Traditional

IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL

K023304 · Diagnostic Products Corp. · Chemistry
Dec 2002
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K023304 is an FDA 510(k) clearance for the IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL, a Radioimmunoassay, Calcitonin (Class II — Special Controls, product code JKR), submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on December 9, 2002, 67 days after receiving the submission on October 3, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1140.

Submission Details

510(k) Number K023304 FDA.gov
FDA Decision Cleared SESE
Date Received October 03, 2002
Decision Date December 09, 2002
Days to Decision 67 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

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

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