510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K223405Substantially Equivalent

Access Testosterone

Siemens Healthcare Diagnostics Inc., Chaska MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K223405 is the FDA 510(k) clearance record for Access Testosterone, a class I device, cleared for Beckman Coulter, Inc. on under FDA product code CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show one recall naming K223405.

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
Beckman Coulter, Inc. 1000 Lake Hazeltine Dr., Chaska MN
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