OSOM STREP A TEST— 510(k) K961423

Substantially Equivalent

Wyntek Diagnostics, Inc.

FDA 510(k) clearance K961423 for OSOM STREP A TEST, Substantially Equivalent on 1996-10-11. Applicant: Wyntek Diagnostics, Inc..

Clearance details

Applicant: Wyntek Diagnostics, Inc.
Product code: Code GTZ
Advisory panel: Microbiology
Date received: 1996-04-12
Decision date: 1996-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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