RISTOCETIN COFACTOR ASSAY

Test, Qualitative And Quantitative Factor Deficiency

HELENA LABORATORIES

The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Ristocetin Cofactor Assay.

Pre-market Notification Details

• Device ID: K840329
• 510k Number: K840329
• Device Name: RISTOCETIN COFACTOR ASSAY
• Classification: Test, Qualitative And Quantitative Factor Deficiency
• Applicant: HELENA LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: GGP
• CFR Regulation Number: 864.7290 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1984-01-25
• Decision Date: 1984-04-05

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M52553650	K840329	000