Cleared Traditional

IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE 2000 INTACT PTH, MODEL L2KPP (200 TESTS), L2K6

K011505 · Diagnostic Products Corp. · Chemistry
Jul 2001
Decision
47d
Days
Class 2
Risk

About This 510(k) Submission

K011505 is an FDA 510(k) clearance for the IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE 2000 INTACT PTH, MODEL L2KPP (200 TESTS), L2K6, a Radioimmunoassay, Parathyroid Hormone (Class II — Special Controls, product code CEW), submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on July 2, 2001, 47 days after receiving the submission on May 16, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1545.

Submission Details

510(k) Number K011505 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 2001
Decision Date July 02, 2001
Days to Decision 47 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CEW — Radioimmunoassay, Parathyroid Hormone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1545

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