EASY-TEST AMYLASE (AMYL), ITEM NUMBER 19019— 510(k) K874705

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K874705 for EASY-TEST AMYLASE (AMYL), ITEM NUMBER 19019, Substantially Equivalent on 1987-12-22. Applicant: Em Diagnostic Systems, Inc..

Clearance details

Applicant
Em Diagnostic Systems, Inc.
Product code
Code JEJ
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Gibbstown, NJ, US
Download summary PDFView on FDA.gov ↗

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