510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K063145Substantially Equivalent

Phenobarbital, Phenytoin, Tdm Calibration Set B and Abtrol/nortrol Controls

Thermo Electron Oy, Vantaa, FI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063145 is the FDA 510(k) clearance record for PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS, a class II device, cleared for Thermo Electron OY on under FDA product code DIP (Enzyme Immunoassay, Diphenylhydantoin). FDA records list 14 510(k) clearances for Thermo Electron OY, from to . As of , FDA records show no recalls naming K063145.

Clearance record

Decision date
Received
(366 days to decision)
Product code
DIP Enzyme Immunoassay, Diphenylhydantoin
Regulation
21 CFR 862.3350
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Thermo Electron OY Ratastie 2, Vantaa, FI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DIP

Trailing 12 months

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

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