COAGULATION CONTROL CONTAINING HEMOGLOBIN

System, Multipurpose For In Vitro Coagulation Studies

ANALYTICAL CONTROL SYSTEMS, INC.

The following data is part of a premarket notification filed by Analytical Control Systems, Inc. with the FDA for Coagulation Control Containing Hemoglobin.

Pre-market Notification Details

• Device ID: K925340
• 510k Number: K925340
• Device Name: COAGULATION CONTROL CONTAINING HEMOGLOBIN
• Classification: System, Multipurpose For In Vitro Coagulation Studies
• Applicant: ANALYTICAL CONTROL SYSTEMS, INC. 155 E. MARKET, SUITE 502 Indianapolis, IN 46204
• Contact: Roy Speck
• Correspondent: Roy Speck; ANALYTICAL CONTROL SYSTEMS, INC. 155 E. MARKET, SUITE 502 Indianapolis, IN 46204
• Product Code: JPA
• CFR Regulation Number: 864.5425 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-10-20
• Decision Date: 1993-03-23

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00817869020311	K925340	000
00817869020274	K925340	000
00817869020267	K925340	000
00817869020250	K925340	000