510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K143075Substantially Equivalent

ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set

Tosoh Bioscience Inc, South San Franciso CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K143075 is the FDA 510(k) clearance record for ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set, a class I device, cleared for Tosoh Bioscience, Inc. on under FDA product code CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone). FDA records list 20 510(k) clearances for Tosoh Bioscience, Inc., from to . As of , FDA records show one recall naming K143075.

Clearance record

Decision date
Received
(248 days to decision)
Product code
CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Regulation
21 CFR 862.1680
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Tosoh Bioscience, Inc. 6000 Shoreline Ct., Suite 101, South San Franciso 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