HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2

System, Multipurpose For In Vitro Coagulation Studies

INSTRUMENTATION LABORATORY CO.

The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Hemosil Special Test Controls Level 1 & 2.

Pre-market Notification Details

• Device ID: K040359
• 510k Number: K040359
• Device Name: HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2
• Classification: System, Multipurpose For In Vitro Coagulation Studies
• Applicant: INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford, MA 01730
• Contact: Carol Marble
• Correspondent: Carol Marble; INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford, MA 01730
• Product Code: JPA
• CFR Regulation Number: 864.5425 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-02-13
• Decision Date: 2004-03-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08426950453062	K040359	000
08426950442189	K040359	000