K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C

Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control

KAMIYA BIOMEDICAL CO.

The following data is part of a premarket notification filed by Kamiya Biomedical Co. with the FDA for K-assay D-dimer, K-assay D-dimer Calibrator, Models Kai-090; Kaj-091c.

Pre-market Notification Details

• Device ID: K030687
• 510k Number: K030687
• Device Name: K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C
• Classification: Fibrinogen And Fibrin Split Products, Antigen, Antiserum, 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: DAP
• CFR Regulation Number: 864.7320 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-03-05
• Decision Date: 2003-06-27

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00816426020665	K030687	000
00816426020368	K030687	000