Olympus Au 5000 Chemistry Analyzer System
FDA 510(k) K860080 · Olympus Corp.
510(k) numberK860080
Submission
- Device name
- Olympus Au 5000 Chemistry Analyzer System
- Applicant
- Olympus Corp.
Lake Success, NY, US - Received
- January 8, 1986
- Decision date
- January 24, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2160
- Specialty
- Clinical Chemistry
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Questions and answers
When was Olympus Au 5000 Chemistry Analyzer System cleared by the FDA?
Olympus Au 5000 Chemistry Analyzer System (K860080) received a 510(k) decision of Substantially Equivalent on January 24, 1986, 16 days after the submission was received.
What is the product code of K860080?
The FDA product code is JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2160.