510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K813411Substantially Equivalent

Document Linearity Test Standards

North American Standards, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K813411 is the FDA 510(k) clearance record for DOCUMENT LINEARITY TEST STANDARDS, a class II device, cleared for North American Standards on under FDA product code JIX (Calibrator, Multi-Analyte Mixture). FDA records list one 510(k) clearance for North American Standards. As of , FDA records show no recalls naming K813411.

Clearance record

Decision date
Received
(14 days to decision)
Product code
JIX Calibrator, Multi-Analyte Mixture
Regulation
21 CFR 862.1150
Device class
Class II
Review panel
Clinical Chemistry
Applicant
North American Standards 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JIX

Trailing 12 months

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

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