DETECTADOT SYSTEM 2000 HETEROPHILE TEST— 510(k) K895891

Substantially Equivalent

Gull Laboratories, Inc.

FDA 510(k) clearance K895891 for DETECTADOT SYSTEM 2000 HETEROPHILE TEST, Substantially Equivalent on 1989-10-31. Applicant: Gull Laboratories, Inc..

Clearance details

Applicant
Gull Laboratories, Inc.
Product code
Code KTN
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Salt Lake City, UT, US
Download summary PDFView on FDA.gov ↗

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