An official website of the United States government Here’s how you know

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

In this section: Substantially Equivalent 510(k) Device Information

BK180301 - PK7400 TP HA Controls and PK7400 TP HA Reagent

510(k) Number: BK180301
Applicant: Newmarket Biomedical Ltd.
Device Name: PK7400 TP HA Controls and PK7400 TP HA Reagent
Decision Date: 8/1/2019

Supporting Documents

BK180301 Letter
BK180301 Summary
BK180301 PK7400 TP HA Controls Instructions for Use
BK180301 PK7400 TP HA Reagent Instructions for Use

Top