Spirit Chemistry System
FDA 510(k) K833116 · Baker Instructions Corp.
510(k) numberK833116
Submission
- Device name
- Spirit Chemistry System
- Applicant
- Baker Instructions Corp.
Mchenry, IL, US - Received
- September 13, 1983
- Decision date
- November 7, 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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| 510(k) | Device | Decision |
|---|---|---|
| K882612 | System 9000 Diff Model Automated Cell CounterGKZ · Traditional | 09/07/1988SE |
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| K870603 | System 9000 Automated Cell CounterGKL · Traditional | 03/31/1987SE |
| K854173 | Ucd Urine Specimen CollectorKNX · Traditional | 11/04/1985SE |
| K850386 | System 8000 Cell CounterGKL · Traditional | 05/02/1985SE |
| K832716 | Encore Chemistry AnalyzerJJG · Traditional | 10/04/1983SE |
| K830641 | Encore Chemistry AnalyzerJJG · Traditional | 04/05/1983SE |
| K821956 | Haem-C Plus Blood Reference ControlsJCN · Traditional | 07/30/1982SE |
| K811694 | Centrifichem Alt/Agpt Optimized ReagentCKA · Traditional | 07/01/1981SE |
Questions and answers
When was Spirit Chemistry System cleared by the FDA?
Spirit Chemistry System (K833116) received a 510(k) decision of Substantially Equivalent on November 7, 1983, 55 days after the submission was received.
What is the product code of K833116?
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.