510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864966Substantially Equivalent

Estrone Analysis Products Radioimmunoassay Estrone

Diagnostics Biochem Canada, Inc., London, Ontario, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864966 is the FDA 510(k) clearance record for ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE, a class I device, cleared for Diagnostics Biochem Canada, Inc. on under FDA product code CGF (Radioimmunoassay, Estrone). FDA records list 6 510(k) clearances for Diagnostics Biochem Canada, Inc., from to . As of , FDA records show no recalls naming K864966.

Clearance record

Decision date
Received
(18 days to decision)
Product code
CGF Radioimmunoassay, Estrone
Regulation
21 CFR 862.1280
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Diagnostics Biochem Canada, Inc. 1020 Hargrieve Rd., London, Ontario, CA
Third party review
No

Clearances, product code CGF

Trailing 12 months

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

FDA records show no clearances under product code CGF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CGF, 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