510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K021972Substantially Equivalent

Fastpack Total Testosterone Immunoassay

Qualigen Inc, Carlsbad CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K021972 is the FDA 510(k) clearance record for FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY, a class I device, cleared for Qualigen, Inc. on under FDA product code CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone). FDA records list 15 510(k) clearances for Qualigen, Inc., from to . As of , FDA records show one recall naming K021972.

Clearance record

Decision date
Received
(65 days to decision)
Product code
CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Regulation
21 CFR 862.1680
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Qualigen, Inc. 2042 Corte Del Nogal, Carlsbad CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CDZ

Trailing 12 months
1 clearance under product code CDZ in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CDZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260