Cleared Traditional

INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY

K963289 · Incstar Corp. · Microbiology
May 1997
Decision
253d
Days
Class 2
Risk

About This 510(k) Submission

K963289 is an FDA 510(k) clearance for the INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY, a Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (Class II — Special Controls, product code LGD), submitted by Incstar Corp. (Stillwater, US). The FDA issued a Cleared decision on May 1, 1997, 253 days after receiving the submission on August 21, 1996. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3780.

Submission Details

510(k) Number K963289 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 1996
Decision Date May 01, 1997
Days to Decision 253 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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