510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K120009Substantially Equivalent

Testosterone Test System; Calibrator; and Quality Control Material (Assayed and Unassayed)

Abbott Medical, Abbott Park IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K120009 is the FDA 510(k) clearance record for TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED), a class I device, cleared for Abbott Laboratories on under FDA product code CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K120009.

Clearance record

Decision date
Received
(252 days to decision)
Product code
CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Regulation
21 CFR 862.1680
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Abbott Laboratories 100 Abbott Park Rd., Abbott Park IL
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 November 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CDZ, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260