OLYMPUS C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC REAGENT

System, Test, C-reactive Protein

OLYMPUS AMERICA, INC.

The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus C-reactive Protein Immunoturbidimetric Reagent.

Pre-market Notification Details

• Device ID: K954537
• 510k Number: K954537
• Device Name: OLYMPUS C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC REAGENT
• Classification: System, Test, C-reactive Protein
• Applicant: OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157
• Contact: Laura Storms-tyler
• Correspondent: Laura Storms-tyler; OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157
• Product Code: DCN
• CFR Regulation Number: 866.5270 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-09-29
• Decision Date: 1996-02-14

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
15099590010447	K954537	000