Cleared Traditional

SERAQUEST CMV IGG

K954191 · Quest Intl., Inc. · Microbiology
Feb 1996
Decision
170d
Days
Class 2
Risk

About This 510(k) Submission

K954191 is an FDA 510(k) clearance for the SERAQUEST CMV IGG, 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 February 23, 1996, 170 days after receiving the submission on September 6, 1995. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number K954191 FDA.gov
FDA Decision Cleared SESE
Date Received September 06, 1995
Decision Date February 23, 1996
Days to Decision 170 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

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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