Demand Analyzer System
FDA 510(k) K831477 · Worthington Diagnostic Systems
510(k) numberK831477
Submission
- Device name
- Demand Analyzer System
- Applicant
- Worthington Diagnostic Systems
Mchenry, IL, US - Received
- May 9, 1983
- Decision date
- June 17, 1983
- 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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More from Ortho-Clinical Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K833708 | Compur* M1000 Hemoglobin & ErythrocyteLKZ · Traditional | 01/04/1984SE |
| K832785 | Compur* Easy Touch Uric Acid ReagentKNK · Traditional | 10/14/1983SE |
| K832749 | Easytouch Bun Reagent SetCDQ · Traditional | 10/14/1983SE |
| K832748 | Compur* Easytouch Total BilirubinCIG · Traditional | 10/14/1983SE |
| K832427 | Easytouch Tromboplastin ReagentGJS · Traditional | 10/14/1983SE |
| K832750 | Easytouch Hemoglobin ReagentKHG · Traditional | 09/26/1983SE |
| K832426 | Easytouch Triglycerides Reagent SetCDT · Traditional | 09/12/1983SE |
| K831318 | Compur* M1100 Hematrcrit SystemJPI · Traditional | 06/08/1983SE |
| K831227 | Compur Easy Touch Chemistry Analyzer-JJF · Traditional | 06/02/1983SE |
| K831103 | Tia-Igm Reagent & Calibrator SetsDFT · Traditional | 04/27/1983SE |
Questions and answers
When was Demand Analyzer System cleared by the FDA?
Demand Analyzer System (K831477) received a 510(k) decision of Substantially Equivalent on June 17, 1983, 39 days after the submission was received.
What is the product code of K831477?
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.