BIOTROL ALKALINE PHOSPHATASE— 510(k) K881742

Substantially Equivalent

Biotrol, USA, Inc.

FDA 510(k) clearance K881742 for BIOTROL ALKALINE PHOSPHATASE, Substantially Equivalent on 1988-07-08. Applicant: Biotrol, USA, Inc..

Clearance details

Applicant: Biotrol, USA, Inc.
Product code: Code CJE
Advisory panel: Clinical Chemistry
Date received: 1988-04-22
Decision date: 1988-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.