SPIFE

Electrophoretic, Protein Fractionation

HELENA LABORATORIES

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

Pre-market Notification Details

• Device ID: K972274
• 510k Number: K972274
• Device Name: SPIFE
• Classification: Electrophoretic, Protein Fractionation
• 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: CEF
• CFR Regulation Number: 862.1630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-06-18
• Decision Date: 1997-10-27

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M52516220030	K972274	000
M52510690000	K972274	000
M52510880010	K972274	000
M52510880020	K972274	000
M52510890010	K972274	000
M52510890020	K972274	000
M52510330000	K972274	000
M52516500000	K972274	000
M52516200030	K972274	000
M52516210030	K972274	000
M52510680010	K972274	000