AUTO TROL(TM) CONTROL, LEVELS 1 & 2 #16692 & 16693— 510(k) K881229

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K881229 for AUTO TROL(TM) CONTROL, LEVELS 1 & 2 #16692 & 16693, Substantially Equivalent on 1988-05-27. Applicant: Em Diagnostic Systems, Inc..

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code JJY
Advisory panel: Clinical Chemistry
Date received: 1988-03-22
Decision date: 1988-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

Download summary PDF View on FDA.gov ↗

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