Cleared Traditional

SERAQUEST TOXOPLASMA IGG

K960092 · Quest Intl., Inc. · Microbiology
Jun 1996
Decision
158d
Days
Class 2
Risk

About This 510(k) Submission

K960092 is an FDA 510(k) clearance for the SERAQUEST TOXOPLASMA IGG, a Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (Class II — Special Controls, product code LGD), submitted by Quest Intl., Inc. (North Miami, US). The FDA issued a Cleared decision on June 17, 1996, 158 days after receiving the submission on January 11, 1996. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3780.

Submission Details

510(k) Number K960092 FDA.gov
FDA Decision Cleared SESE
Date Received January 11, 1996
Decision Date June 17, 1996
Days to Decision 158 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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