Cleared Traditional

SEROCARD HSV IGG ANTIBODY TEST KIT

K903070 · Disease Detection International, Inc. · Microbiology

Aug 1990

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K903070 is an FDA 510(k) clearance for the SEROCARD HSV IGG ANTIBODY TEST KIT, a Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific (Class II — Special Controls, product code LGC), submitted by Disease Detection International, Inc. (Irvine, US). The FDA issued a Cleared decision on August 9, 1990, 28 days after receiving the submission on July 12, 1990. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number	K903070 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 12, 1990
Decision Date	August 09, 1990
Days to Decision	28 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—

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