510(k) K874761— RAPID COLORIMETRIC DIRECT STREP A TEST

Substantially Equivalent

New Horizons Diagnostics Co.

Clearance details

Applicant: New Horizons Diagnostics Co.
Product code: Code GTZ
Advisory panel: Microbiology
Date received: 1987-11-19
Decision date: 1988-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

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