WAKO(TM) AUTOKIT AMYLASE— 510(k) K883059

Substantially Equivalent

Wako Chemicals USA, Inc.

FDA 510(k) clearance K883059 for WAKO(TM) AUTOKIT AMYLASE, Substantially Equivalent on 1988-08-30. Applicant: Wako Chemicals USA, Inc..

Clearance details

Applicant: Wako Chemicals USA, Inc.
Product code: Code CJA
Advisory panel: Clinical Chemistry
Date received: 1988-07-19
Decision date: 1988-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

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