510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K854028Substantially Equivalent

Audit Automated Blood Chemistry Analyzer

Verified Medical Research, Inc., Tempe AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854028 is the FDA 510(k) clearance record for AUDIT AUTOMATED BLOOD CHEMISTRY ANALYZER, a class II device, cleared for Verified Medical Research, Inc. on under FDA product code JIW (Calibrator, Surrogate). FDA records list one 510(k) clearance for Verified Medical Research, Inc. As of , FDA records show no recalls naming K854028.

Clearance record

Decision date
Received
(62 days to decision)
Product code
JIW Calibrator, Surrogate
Regulation
21 CFR 862.1150
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Verified Medical Research, Inc. 124 E. Harvard, Tempe AZ
Third party review
No

Clearances, product code JIW

Trailing 12 months

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

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