Cleared Traditional

K963282 - SERAQUEST HSV IGG
(FDA 510(k) Clearance)

K963282 · Quest Intl., Inc. · Microbiology

Jan 1997

Decision

154d

Days

Class 2

Risk

K963282 is an FDA 510(k) clearance for the SERAQUEST HSV IGG, a Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific (Class II — Special Controls, product code LGC), submitted by Quest Intl., Inc. (North Miami, US). The FDA issued a Cleared decision on January 22, 1997, 154 days after receiving the submission on August 21, 1996. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number	K963282 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 21, 1996
Decision Date	January 22, 1997
Days to Decision	154 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	LGC — Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3305