K-ASSAY HS-CRP CONTROLS

C-reactive Protein, Antigen, Antiserum, And Control

KAMIYA BIOMEDICAL CO.

The following data is part of a premarket notification filed by Kamiya Biomedical Co. with the FDA for K-assay Hs-crp Controls.

Pre-market Notification Details

• Device ID: K022486
• 510k Number: K022486
• Device Name: K-ASSAY HS-CRP CONTROLS
• Classification: C-reactive Protein, Antigen, Antiserum, And Control
• Applicant: KAMIYA BIOMEDICAL CO. 910 INDUSTRY DR. Seattle, WA 98188 -3412
• Contact: Brian Schliesman
• Correspondent: Brian Schliesman; KAMIYA BIOMEDICAL CO. 910 INDUSTRY DR. Seattle, WA 98188 -3412
• Product Code: DCK
• CFR Regulation Number: 866.5270 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-07-29
• Decision Date: 2002-08-14

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00816426020887	K022486	000