APTT-P REAGENT, A PARTICLE ACTIVATED REAGENT

Activated Partial Thromboplastin

MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Medical Diagnostic Technologies, Inc. with the FDA for Aptt-p Reagent, A Particle Activated Reagent.

Pre-market Notification Details

• Device ID: K895255
• 510k Number: K895255
• Device Name: APTT-P REAGENT, A PARTICLE ACTIVATED REAGENT
• Classification: Activated Partial Thromboplastin
• Applicant: MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. 6020 NICOLLE ST., STE. D Ventura, CA 93003
• Contact: Michael D Bick,phd
• Correspondent: Michael D Bick,phd; MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. 6020 NICOLLE ST., STE. D Ventura, CA 93003
• Product Code: GFO
• CFR Regulation Number: 864.7925 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1989-08-21
• Decision Date: 1989-10-06

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
15391521420517	K895255	000