TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL— 510(k) K970100

Substantially Equivalent

Simplicity Diagnostics, Inc.

FDA 510(k) clearance K970100 for TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL, Substantially Equivalent on 1997-03-10. Applicant: Simplicity Diagnostics, Inc..

Clearance details

Applicant: Simplicity Diagnostics, Inc.
Product code: Code MJX
Advisory panel: Clinical Chemistry
Date received: 1997-01-10
Decision date: 1997-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hatboro, PA, US

Download summary PDF View on FDA.gov ↗

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