SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389— 510(k) K024162

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K024162 for SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389, Substantially Equivalent on 2003-02-19. Applicant: Helena Laboratories.

Clearance details

Applicant
Helena Laboratories
Product code
Code CFF
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Beaumont, TX, US
Download summary PDFView on FDA.gov ↗

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