MILES URINE AMYLASE METHOD— 510(k) K923105

Substantially Equivalent

Heraeus Kulzer, Inc.

FDA 510(k) clearance K923105 for MILES URINE AMYLASE METHOD, Substantially Equivalent on 1992-09-28. Applicant: Heraeus Kulzer, Inc..

Clearance details

Applicant: Heraeus Kulzer, Inc.
Product code: Code JFJ
Advisory panel: Clinical Chemistry
Date received: 1992-06-19
Decision date: 1992-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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