RFA/2 Rapid Flow Analyzer W/Computer
FDA 510(k) K890332 · Alpkem Corp.
510(k) numberK890332
Submission
- Device name
- RFA/2 Rapid Flow Analyzer W/Computer
- Applicant
- Alpkem Corp.
Clackamas, OR, US - Received
- January 23, 1989
- Decision date
- February 17, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJC – Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2150
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JJC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K945915 | Avl Omni AnalyzerJJC · Traditional | Avl Scientific Corp. | 04/05/1995SE |
| K945584 | Nova 16 AnalyzerJJC · Traditional | Nova Biomedical Corp. | 02/08/1995SE |
| K943376 | Opera SystemJJC · Traditional | Miles, Inc. | 09/14/1994SE |
| K901410 | Technicon RA-2000(TM) SystemJJC · Traditional | Technicon Instruments Corp. | 07/17/1990SE |
| K901141 | Paramax 520, Paramax 720 and Paramax 720ZXJJC · Traditional | Baxter Healthcare Corp | 04/09/1990SE |
| K881056 | Amresco Flow Pac Random Access Liquid #4901030JJC · Traditional | American Research Products Co. | 11/15/1988SE |
| K875105 | Technicon Smac 3 SystemJJC · Traditional | Technicon Instruments Corp. | 02/16/1988SE |
| K870998 | Technicon Ra-Xt(Tm) System ImmunoassaysJJC · Traditional | Technicon Instruments Corp. | 05/26/1987SE |
| K862561 | Technicon Ra-Xt System with AnalytesJJC · Traditional | Technicon Instruments Corp. | 10/20/1986SE |
| K854345 | Technicon RA-500 SystemJJC · Traditional | Technicon Instruments Corp. | 11/26/1985SE |
More from Technicon Instruments Corp.
| 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 |
| K883020 | RFA-300 Rapid Flow Analyzer W/ComputerJJF · Traditional | 09/02/1988SE |
| K860367 | Magnesium (Substrate, Enzyme, Reagent)JGF · Traditional | 04/11/1986SE |
| K852005 | MG ReagentJGJ · Traditional | 06/25/1985SE |
Questions and answers
When was RFA/2 Rapid Flow Analyzer W/Computer cleared by the FDA?
RFA/2 Rapid Flow Analyzer W/Computer (K890332) received a 510(k) decision of Substantially Equivalent on February 17, 1989, 25 days after the submission was received.
What is the product code of K890332?
The FDA product code is JJC – Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2150.