PULSE CRP TEST

C-reactive Protein, Antigen, Antiserum, And Control

PULSE SCIENTIFIC, INC.

The following data is part of a premarket notification filed by Pulse Scientific, Inc. with the FDA for Pulse Crp Test.

Pre-market Notification Details

• Device ID: K923768
• 510k Number: K923768
• Device Name: PULSE CRP TEST
• Classification: C-reactive Protein, Antigen, Antiserum, And Control
• Applicant: PULSE SCIENTIFIC, INC. 5125 HARVESTER ROAD UNIT 6 Burlington, Ont., Canada, CA L7l 6a2
• Contact: Allen Chan
• Correspondent: Allen Chan; PULSE SCIENTIFIC, INC. 5125 HARVESTER ROAD UNIT 6 Burlington, Ont., Canada, CA L7l 6a2
• Product Code: DCK
• CFR Regulation Number: 866.5270 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-07-28
• Decision Date: 1992-12-01

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00628055726029	K923768	000