ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770

Activated Whole Blood Clotting Time

HELENA LABORATORIES

The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Actalyke Xl Activated Clotting Time Analyzer, Model 5770.

Pre-market Notification Details

• Device ID: K020914
• 510k Number: K020914
• Device Name: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770
• Classification: Activated Whole Blood Clotting Time
• Applicant: HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704
• Contact: Patricia Franks
• Correspondent: Patricia Franks; HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704
• Product Code: JBP
• CFR Regulation Number: 864.7140 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-03-21
• Decision Date: 2002-05-23

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M52557700040	K020914	000
M52557700030	K020914	000
M52557700020	K020914	000
M52557700010	K020914	000