510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K041871Substantially Equivalent

Interlab Microcal Serum Controls

Trouble Shooter Consuling, Inc., Rome, IT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K041871 is the FDA 510(k) clearance record for INTERLAB MICROCAL SERUM CONTROLS, a class I device, cleared for Trouble Shooter Consuling, Inc. on under FDA product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)). FDA records list one 510(k) clearance for Trouble Shooter Consuling, Inc. As of , FDA records show no recalls naming K041871.

Clearance record

Decision date
Received
(38 days to decision)
Product code
JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Regulation
21 CFR 862.1660
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Trouble Shooter Consuling, Inc. Via Rina Monti N 26 C.A.P., Rome, IT
510(k) summary
Statement
Third party review
No

Clearances, product code JJX

Trailing 12 months

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

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