RFA-300 Rapid Flow Analyzer W/Computer
FDA 510(k) K883020 · Alpkem Corp.
510(k) numberK883020
Submission
- Device name
- RFA-300 Rapid Flow Analyzer W/Computer
- Applicant
- Alpkem Corp.
Clackamas, OR, US - Received
- July 19, 1988
- Decision date
- September 2, 1988
- 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 |
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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 |
|---|---|---|
| K894011 | Total GalactoseKQP · Traditional | 01/11/1990SE |
| K891070 | Phenylalanine (Ninhydrin Reaction)JNB · Traditional | 10/27/1989SE |
| K890334 | Total Cholesterol ReagentCHH · Traditional | 05/03/1989SE |
| K890337 | Triglycerides - Gpo ReagentCDT · Traditional | 03/09/1989SE |
| K890336 | Glucose (God) ReagentCGA · Traditional | 02/27/1989SE |
| K890335 | Sodium Hydroxide Solution, Creatinine Reag./Dilu.CGE · Traditional | 02/17/1989SE |
| K890333 | Albumin ReagentEIX · Traditional | 02/17/1989SE |
| K890332 | RFA/2 Rapid Flow Analyzer W/ComputerJJC · Traditional | 02/17/1989SE |
| K860367 | Magnesium (Substrate, Enzyme, Reagent)JGF · Traditional | 04/11/1986SE |
| K852005 | MG ReagentJGJ · Traditional | 06/25/1985SE |
Questions and answers
When was RFA-300 Rapid Flow Analyzer W/Computer cleared by the FDA?
RFA-300 Rapid Flow Analyzer W/Computer (K883020) received a 510(k) decision of Substantially Equivalent on September 2, 1988, 45 days after the submission was received.
What is the product code of K883020?
The FDA product code is JJF – Analyzer, Chemistry, Micro, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2170.