510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K083867Substantially Equivalent

Access Sex Hormone Binding Globulin Reagent, Access Sex Hormone Binding Globulin Calibrators and Access Sex Hormone Bind

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

K083867 is the FDA 510(k) clearance record for ACCESS SEX HORMONE BINDING GLOBULIN REAGENT, ACCESS SEX HORMONE BINDING GLOBULIN CALIBRATORS AND ACCESS SEX HORMONE BIND, 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 K083867.

Clearance record

Decision date
Received
(241 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