Cleared Traditional

ORTHO HSV ANTIGEN ELISA TEST, MODIFICATION

K925208 · Ortho Diagnostic Systems, Inc. · Microbiology

Dec 1992

Decision

91d

Days

Class 2

Risk

About This 510(k) Submission

K925208 is an FDA 510(k) clearance for the ORTHO HSV ANTIGEN ELISA TEST, MODIFICATION, a Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific (Class II — Special Controls, product code LGC), submitted by Ortho Diagnostic Systems, Inc. (Carpinteria, US). The FDA issued a Cleared decision on December 28, 1992, 91 days after receiving the submission on September 28, 1992. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number	K925208 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 28, 1992
Decision Date	December 28, 1992
Days to Decision	91 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