COLOCARE

Reagent, Occult Blood

HELENA LABORATORIES

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

Pre-market Notification Details

• Device ID: K905798
• 510k Number: K905798
• Device Name: COLOCARE
• Classification: Reagent, Occult Blood
• Applicant: HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704
• Contact: Pat Franks
• Correspondent: Pat Franks; HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704
• Product Code: KHE
• CFR Regulation Number: 864.6550 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-11-19
• Decision Date: 1991-07-03