Winmax Software Systems
FDA 510(k) K965103 · Diagnostic Products Corp.
510(k) numberK965103
Submission
- Device name
- Winmax Software Systems
- Applicant
- Diagnostic Products Corp.
Los Angeles, CA, US - Received
- December 20, 1996
- Decision date
- May 9, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJF – Analyzer, Chemistry, Micro, For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2170
- Specialty
- Clinical Chemistry
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Questions and answers
When was Winmax Software Systems cleared by the FDA?
Winmax Software Systems (K965103) received a 510(k) decision of Substantially Equivalent on May 9, 1997, 140 days after the submission was received.
What is the product code of K965103?
The FDA product code is JJF – Analyzer, Chemistry, Micro, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2170.