OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH

Cardiac C-reactive Protein, Antigen, Antiserum, And Control

OLYMPUS AMERICA, INC.

The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Crp Latex Reagent, Osr6199; Olympus Crp Latex Calibrator Normal Set, Odc0026; Olympus Crp Latex Calibrator High.

Pre-market Notification Details

• Device ID: K051564
• 510k Number: K051564
• Device Name: OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH
• Classification: Cardiac C-reactive Protein, Antigen, Antiserum, And Control
• Applicant: OLYMPUS AMERICA, INC. 3131 WEST ROYAL LN. Irving, TX 75063 -3104
• Contact: Bev Harding
• Correspondent: Bev Harding; OLYMPUS AMERICA, INC. 3131 WEST ROYAL LN. Irving, TX 75063 -3104
• Product Code: NQD
• CFR Regulation Number: 866.5270 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-06-14
• Decision Date: 2005-08-22

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
15099590070564	K051564	000
15099590070557	K051564	000
15099590010959	K051564	000