Progress Selective Dhemistry Analyz
FDA 510(k) K840200 · Kone Instruments, Inc.
510(k) numberK840200
Submission
- Device name
- Progress Selective Dhemistry Analyz
- Applicant
- Kone Instruments, Inc.
Mchenry, IL, US - Received
- January 19, 1984
- Decision date
- April 4, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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More from Synermed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K873345 | 'Microlyte 4/5'JFP · Traditional | 09/11/1987SE |
| K870777 | Progress Plus Selective Chemistry AnalyzerJJF · Traditional | 03/13/1987SE |
| K863466 | M700 Stress MonitorDRT · Traditional | 12/22/1986SE |
| K862655 | Signa II Resting ECG ElectrodeDRX · Traditional | 08/06/1986SE |
| K860767 | Model E 600 ElectrocardiographDSI · Traditional | 04/23/1986SE |
| K853354 | Medic 4LDD · Traditional | 10/11/1985SE |
| K830433 | Patient Monitor 575DRT · Traditional | 03/24/1983SE |
| K830432 | Central Station 590DRT · Traditional | 03/24/1983SE |
| K822952 | 560DRT · Traditional | 11/01/1982SE |
| K820541 | MicrolyteJJF · Traditional | 05/24/1982SE |
Questions and answers
When was Progress Selective Dhemistry Analyz cleared by the FDA?
Progress Selective Dhemistry Analyz (K840200) received a 510(k) decision of Substantially Equivalent on April 4, 1984, 76 days after the submission was received.
What is the product code of K840200?
The FDA product code is JJF – Analyzer, Chemistry, Micro, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2170.