510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K882559Substantially Equivalent

Profile One Omni

Modular Diagnostic Systems, Inc., Syracuse NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882559 is the FDA 510(k) clearance record for PROFILE ONE OMNI, a class I device, cleared for Modular Diagnostic Systems, Inc. on under FDA product code JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use). FDA records list one 510(k) clearance for Modular Diagnostic Systems, Inc. As of , FDA records show no recalls naming K882559.

Clearance record

Decision date
Received
(48 days to decision)
Product code
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Regulation
21 CFR 862.2160
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Modular Diagnostic Systems, Inc. 227 W. Fayette St., Syracuse NY
Third party review
No

Clearances, product code JJE

Trailing 12 months

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

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