510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K850815Substantially Equivalent

Radioisotope Calibrator Model 34-062

Victoreen, Inc., Carle Place NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850815 is the FDA 510(k) clearance record for RADIOISOTOPE CALIBRATOR MODEL 34-062, a class II device, cleared for Victoreen, Inc. on under FDA product code KPT (Calibrator, Dose, Radionuclide). FDA records list 40 510(k) clearances for Victoreen, Inc., from to . As of , FDA records show no recalls naming K850815.

Clearance record

Decision date
Received
(174 days to decision)
Product code
KPT Calibrator, Dose, Radionuclide
Regulation
21 CFR 892.1360
Device class
Class II
Review panel
Radiology
Applicant
Victoreen, Inc. 100 Voice Rd., Carle Place NY
Third party review
No

Clearances, product code KPT

Trailing 12 months

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

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