HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G

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

MRL DIAGNOSTICS

The following data is part of a premarket notification filed by Mrl Diagnostics with the FDA for Hsv-1 & Hsv-2 Differentiation Immunoblot Igg, Model Ib0900g.

Pre-market Notification Details

• Device ID: K000238
• 510k Number: K000238
• Device Name: HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G
• Classification: Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific
• Applicant: MRL DIAGNOSTICS 10703 PROGRESS WAY Cypress, CA 90630 -4737
• Contact: Michael J Wagner
• Correspondent: Michael J Wagner; MRL DIAGNOSTICS 10703 PROGRESS WAY Cypress, CA 90630 -4737
• Product Code: LGC
• CFR Regulation Number: 866.3305 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-01-27
• Decision Date: 2000-04-14

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20816101021004	K000238	000
10816101021038	K000238	000
10816101021021	K000238	000
10816101021014	K000238	000