510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K874587Substantially Equivalent

Paramax Urine/csf Calibrator

Baxter Healthcare Corporation, Santa Ana CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K874587 is the FDA 510(k) clearance record for PARAMAX URINE/CSF CALIBRATOR, a class II device, cleared for Baxter Healthcare Corp on under FDA product code JIX (Calibrator, Multi-Analyte Mixture). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K874587.

Clearance record

Decision date
Received
(57 days to decision)
Product code
JIX Calibrator, Multi-Analyte Mixture
Regulation
21 CFR 862.1150
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Baxter Healthcare Corp P.O. Box 25101, Santa Ana CA
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