QUICKSTREAM ONE STEP PREGNANCY TEST MODEL NUMBER 9012

Kit, Test, Pregnancy, Hcg, Over The Counter

PHAMATECH

The following data is part of a premarket notification filed by Phamatech with the FDA for Quickstream One Step Pregnancy Test Model Number 9012.

Pre-market Notification Details

• Device ID: K980532
• 510k Number: K980532
• Device Name: QUICKSTREAM ONE STEP PREGNANCY TEST MODEL NUMBER 9012
• Classification: Kit, Test, Pregnancy, Hcg, Over The Counter
• Applicant: PHAMATECH 9265 ACTIVITY RD., #112-113 San Diego, CA 92126
• Contact: Carl A Mongiovi
• Correspondent: Carl A Mongiovi; PHAMATECH 9265 ACTIVITY RD., #112-113 San Diego, CA 92126
• Product Code: LCX
• CFR Regulation Number: 862.1155 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-02-11
• Decision Date: 1998-03-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840239028228	K980532	000