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

Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific

DIAGNOSTIC PRODUCTS CORP.

The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Modification To Immulite Herpes I & Ii Igg, Model L2khs2 & L2khs6.

Pre-market Notification Details

• Device ID: K010878
• 510k Number: K010878
• Device Name: MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6
• Classification: Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific
• Applicant: DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597
• Contact: Edward M Levine
• Correspondent: Edward M Levine; DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597
• Product Code: LGC
• CFR Regulation Number: 866.3305 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-03-19
• Decision Date: 2001-04-18

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00630414999784	K010878	000