Cleared Traditional

IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2, L2KRM6

K012077 · Diagnostic Products Corp. · Microbiology
Jan 2002
Decision
192d
Days
Class 2
Risk

About This 510(k) Submission

K012077 is an FDA 510(k) clearance for the IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2, L2KRM6, a Enzyme Linked Immunoabsorbent Assay, Rubella (Class II — Special Controls, product code LFX), submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on January 10, 2002, 192 days after receiving the submission on July 2, 2001. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number K012077 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 2001
Decision Date January 10, 2002
Days to Decision 192 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LFX — Enzyme Linked Immunoabsorbent Assay, Rubella
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3510

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