SPECTROLYSE FACTOR VII:C

Test, Qualitative And Quantitative Factor Deficiency

MEDITECH, INC.

The following data is part of a premarket notification filed by Meditech, Inc. with the FDA for Spectrolyse Factor Vii:c.

Pre-market Notification Details

• Device ID: K934584
• 510k Number: K934584
• Device Name: SPECTROLYSE FACTOR VII:C
• Classification: Test, Qualitative And Quantitative Factor Deficiency
• Applicant: MEDITECH, INC. 6025 NICOLLE ST. Ventura, CA 93003
• Contact: Michael D Bick, Ph.d
• Correspondent: Michael D Bick, Ph.d; MEDITECH, INC. 6025 NICOLLE ST. Ventura, CA 93003
• Product Code: GGP
• CFR Regulation Number: 864.7290 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-09-23
• Decision Date: 1993-12-06

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05391521420565	K934584	000