Cleared Special

MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6

K010878 · Diagnostic Products Corp. · Microbiology

Apr 2001

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K010878 is an FDA 510(k) clearance for the MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6, a Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific (Class II — Special Controls, product code LGC), submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on April 18, 2001, 30 days after receiving the submission on March 19, 2001. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number	K010878 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 19, 2001
Decision Date	April 18, 2001
Days to Decision	30 days
Submission Type	Special
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