FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY— 510(k) K021972

Clearance details

Applicant

Qualigen, Inc.

Product code

Code CDZ

Device class

Class 1

Regulation

21 CFR 862.1680

Advisory panel

Clinical Chemistry

Date received

2002-06-17

Decision date

2002-08-21

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Carlsbad, CA, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K021972.