IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT

C-reactive Protein, Antigen, Antiserum, And Control

BECKMAN COULTER, INC.

The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Immage Immunochemistry System High Sensitivity C-reactive Protein (crph) Reagent.

Pre-market Notification Details

• Device ID: K010236
• 510k Number: K010236
• Device Name: IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT
• Classification: C-reactive Protein, Antigen, Antiserum, And Control
• Applicant: BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 Brea, CA 92822
• Contact: Annette Hellie
• Correspondent: Annette Hellie; BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 Brea, CA 92822
• Product Code: DCK
• CFR Regulation Number: 866.5270 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-01-25
• Decision Date: 2001-04-05

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
15099590227005	K010236	000