TITAN GEL ALKALINE PHOSPHATASE (HR)— 510(k) K921578

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K921578 for TITAN GEL ALKALINE PHOSPHATASE (HR), Substantially Equivalent on 1992-09-23. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code CIN
Advisory panel: Clinical Chemistry
Date received: 1992-04-02
Decision date: 1992-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

Download summary PDF View on FDA.gov ↗

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