Cleared Traditional

IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM, MODEL L2KTM2 AND L2KTM6

K012075 · Diagnostic Products Corp. · Microbiology
Jan 2002
Decision
192d
Days
Class 2
Risk

About This 510(k) Submission

K012075 is an FDA 510(k) clearance for the IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM, MODEL L2KTM2 AND L2KTM6, a Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (Class II — Special Controls, product code LGD), 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 866.3780.

Submission Details

510(k) Number K012075 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 LGD — Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3780

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