Chemistry Analyzer Impact 400
FDA 510(k) K802609 · Gilford Instrument Laboratories, Inc.
510(k) numberK802609
Submission
- Device name
- Chemistry Analyzer Impact 400
- Applicant
- Gilford Instrument Laboratories, Inc.
Mchenry, IL, US - Received
- October 21, 1980
- Decision date
- November 26, 1980
- 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 |
|---|---|---|
| K823233 | Sba 300 Clinical Chemistry AnalyzerJJC · Traditional | 11/29/1982SE |
| K821583 | Ames/Gilford Optimate Clin. Chem & TherJJF · Traditional | 06/24/1982SE |
| K801889 | Model 203S Clinical Chemistry AnalyzerJJE · Traditional | 09/26/1980SE |
| K800085 | System 203 Chemistry AnalyzerJJE · Traditional | 02/13/1980SE |
| K792361 | System 103 Chemistry AnalyzerJJE · Traditional | 12/27/1979SE |
| K792087 | Microflame PhotometerJJO · Traditional | 11/13/1979SE |
| K791968 | Eia (Elisa) ReaderJJQ · Traditional | 10/17/1979SE |
| K790073 | Analyzer, Impact 100JJI · Traditional | 02/22/1979SE |
| K790072 | Analyzer, Impact 200JJE · Traditional | 02/22/1979SE |
| K781269 | Elisa SystmeJJQ · Traditional | 12/04/1978SE |
Questions and answers
When was Chemistry Analyzer Impact 400 cleared by the FDA?
Chemistry Analyzer Impact 400 (K802609) received a 510(k) decision of Substantially Equivalent on November 26, 1980, 36 days after the submission was received.
What is the product code of K802609?
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.