Cleared Traditional

IMMULITE EPO, MODEL #'S LKEPZ & LKEP1

K983203 · Diagnostic Products Corp. · Hematology
Jul 1999
Decision
301d
Days
Class 2
Risk

About This 510(k) Submission

K983203 is an FDA 510(k) clearance for the IMMULITE EPO, MODEL #'S LKEPZ & LKEP1, a Assay, Erythropoietin (Class II — Special Controls, product code GGT), submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on July 12, 1999, 301 days after receiving the submission on September 14, 1998. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7250.

Submission Details

510(k) Number K983203 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 1998
Decision Date July 12, 1999
Days to Decision 301 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GGT — Assay, Erythropoietin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7250

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