DeviceClearance

FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER— 510(k) K003094

Substantially Equivalent

Qualigen, Inc.

FDA 510(k) clearance K003094 for FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER, Substantially Equivalent on 2000-10-25. Applicant: Qualigen, Inc..

Clearance details

Applicant
Qualigen, Inc.
Product code
Code LTJ
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Carlsbad, CA, US
Download summary PDFView on FDA.gov ↗

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