Ames/Gilford Optimate Clin. Chem & Ther
FDA 510(k) K821583 · Gilford Instrument Laboratories, Inc.
510(k) numberK821583
Submission
- Device name
- Ames/Gilford Optimate Clin. Chem & Ther
- Applicant
- Gilford Instrument Laboratories, Inc.
Mchenry, IL, US - Received
- May 28, 1982
- Decision date
- June 24, 1982
- 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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| 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 |
More from Synermed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K823233 | Sba 300 Clinical Chemistry AnalyzerJJC · Traditional | 11/29/1982SE |
| K802609 | Chemistry Analyzer Impact 400JJE · Traditional | 11/26/1980SE |
| 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 Ames/Gilford Optimate Clin. Chem & Ther cleared by the FDA?
Ames/Gilford Optimate Clin. Chem & Ther (K821583) received a 510(k) decision of Substantially Equivalent on June 24, 1982, 27 days after the submission was received.
What is the product code of K821583?
The FDA product code is JJF – Analyzer, Chemistry, Micro, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2170.