510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K063605Substantially Equivalent

St Aia-Pack Intact Pth Assay

Tosoh Bioscience Inc, Grove City OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063605 is the FDA 510(k) clearance record for ST AIA-PACK INTACT PTH ASSAY, a class II device, cleared for Tosoh Bioscience, Inc. on under FDA product code CEW (Radioimmunoassay, Parathyroid Hormone). FDA records list 20 510(k) clearances for Tosoh Bioscience, Inc., from to . As of , FDA records show no recalls naming K063605.

Clearance record

Decision date
Received
(199 days to decision)
Product code
CEW Radioimmunoassay, Parathyroid Hormone
Regulation
21 CFR 862.1545
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Tosoh Bioscience, Inc. 3600 Gantz Rd., Grove City OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CEW

Trailing 12 months

FDA records hold no clearances under product code CEW in the trailing twelve months.

FDA records show no clearances under product code CEW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CEW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260