Cleared Traditional

SERAQUEST CMV IGM

K982485 · Quest Intl., Inc. · Microbiology
Jan 1999
Decision
180d
Days
Class 2
Risk

About This 510(k) Submission

K982485 is an FDA 510(k) clearance for the SERAQUEST CMV IGM, a Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (Class II — Special Controls, product code LFZ), submitted by Quest Intl., Inc. (North Miami, US). The FDA issued a Cleared decision on January 13, 1999, 180 days after receiving the submission on July 17, 1998. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number K982485 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 1998
Decision Date January 13, 1999
Days to Decision 180 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code LFZ — Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3175

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