Cleared Traditional

K972295 - SERAQUEST VZV IGG
(FDA 510(k) Clearance)

K972295 · Quest Intl., Inc. · Microbiology

Nov 1997

Decision

139d

Days

Class 2

Risk

K972295 is an FDA 510(k) clearance for the SERAQUEST VZV IGG, a Enzyme Linked Immunoabsorbent Assay, Varicella-zoster (Class II — Special Controls, product code LFY), submitted by Quest Intl., Inc. (North Miami, US). The FDA issued a Cleared decision on November 5, 1997, 139 days after receiving the submission on June 19, 1997. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3900.

Submission Details

510(k) Number	K972295 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 19, 1997
Decision Date	November 05, 1997
Days to Decision	139 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement