510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K843440Substantially Equivalent

Mingo Log 7

Siemens Elema AB, Chicago IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843440 is the FDA 510(k) clearance record for MINGO LOG 7, a class II device, cleared for Siemens Elema AB on under FDA product code DJH (Gas Chromatography, Phenobarbital). FDA records list 63 510(k) clearances for Siemens Elema AB, from to . As of , FDA records show no recalls naming K843440.

Clearance record

Decision date
Received
(0 days to decision)
Product code
DJH Gas Chromatography, Phenobarbital
Regulation
21 CFR 862.3660
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Siemens Elema AB Burditt, Bowles & Radzius, Chicago IL
Third party review
No

Clearances, product code DJH

Trailing 12 months

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

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