510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K965103Substantially Equivalent

Winmax Software Systems

Siemens Healthcare Diagnostics Inc., Los Angeles CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K965103 is the FDA 510(k) clearance record for WINMAX SOFTWARE SYSTEMS, a class I device, cleared for Diagnostic Products Corp. on under FDA product code JJF (Analyzer, Chemistry, Micro, For Clinical Use). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show no recalls naming K965103.

Clearance record

Decision date
Received
(140 days to decision)
Product code
JJF Analyzer, Chemistry, Micro, For Clinical Use
Regulation
21 CFR 862.2170
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Diagnostic Products Corp. 5700 W. 96th St., Los Angeles CA
510(k) summary
Summary
Third party review
No

Clearances, product code JJF

Trailing 12 months

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

FDA records show no clearances under product code JJF in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JJF, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260