510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K833406Substantially Equivalent

Immophase D-Te 3 Radioimmunoassay

Corning Medical & Scientific, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K833406 is the FDA 510(k) clearance record for IMMOPHASE D-TE 3 RADIOIMMUNOASSAY, a class I device, cleared for Corning Medical & Scientific on under FDA product code CGF (Radioimmunoassay, Estrone). FDA records list 111 510(k) clearances for Corning Medical & Scientific, from to . As of , FDA records show no recalls naming K833406.

Clearance record

Decision date
Received
(116 days to decision)
Product code
CGF Radioimmunoassay, Estrone
Regulation
21 CFR 862.1280
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Corning Medical & Scientific 803 N. Front St. Suite 3, Mchenry IL
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