Electroly Te Chemistry Analyzer
FDA 510(k) K802398 · Instrumentation Laboratory CO
510(k) numberK802398
Submission
- Device name
- Electroly Te Chemistry Analyzer
- Applicant
- Instrumentation Laboratory CO
Mchenry, IL, US - Received
- October 2, 1980
- Decision date
- October 31, 1980
- 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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| K033734 | Lightcycler Instrument Version 1.2JJF · Traditional | Roche Diagnostics Corp. | 12/17/2003SE |
| K013654 | Precision Systems Analette Chemistry AnalyzerJJF · Traditional | Precision Systems, Inc. | 06/05/2002SE |
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| K993634 | Careside AnalyzerJJF · Traditional | Careside, Inc. | 12/02/1999SE |
| K973628 | Vitalab Flexor/Vitalab Selectra 2/VITALAB VivaJJF · Traditional | Vital Scientific N.V. | 03/13/1998SE |
| K980056 | Careside AnalyzerJJF · Traditional | Exigent Diagnostics, Inc. | 03/06/1998SE |
| K973177 | Mago Automated Eia ProcessorJJF · Traditional | Diamedix Corp. | 10/09/1997SE |
| K971491 | Synermed Ir 200 Chemistry AnalyzerJJF · Traditional | Synermed, Inc. | 06/26/1997SE |
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| K223090 | GEM Premier ChemSTATCGA · Special | 01/27/2023SE |
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Questions and answers
When was Electroly Te Chemistry Analyzer cleared by the FDA?
Electroly Te Chemistry Analyzer (K802398) received a 510(k) decision of Substantially Equivalent on October 31, 1980, 29 days after the submission was received.
What is the product code of K802398?
The FDA product code is JJF – Analyzer, Chemistry, Micro, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2170.