Riause Auto Processor
FDA 510(k) K801030 · Electro-Nucleonics Laboratories, Inc.
510(k) numberK801030
Submission
- Device name
- Riause Auto Processor
- Applicant
- Electro-Nucleonics Laboratories, Inc.
Mchenry, IL, US - Received
- May 1, 1980
- Decision date
- May 28, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JQW – Station, Pipetting And Diluting, For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2750
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JQW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K023955 | BD Viper InstrumentJQW · Traditional | Becton, Dickinson & CO | 06/24/2003SE |
| K973335 | Quatro SP Sample Processing Systems (200-499, Inclusive)JQW · Traditional | Zenyx Scientific , Ltd. | 04/30/1998SE |
| K980180 | 2700 Sample ManagerJQW · Traditional | Waters Corporation | 02/12/1998SE |
| K970420 | Mastercap Am 5.0/MASTERCAP RM 5.0JQW · Traditional | Pharmacia, Inc. | 06/30/1997SE |
| K970616 | Mini Sampler ProcessorJQW · Traditional | Cavro Scientific Instruments, Inc. | 04/21/1997SE |
| K962687 | Gio. de Vita E C. S.R.L.(Gdv) Automatic Washing SystemJQW · Traditional | Nichols Institute Diagnostics | 03/28/1997SE |
| K962859 | Mini Sample ProcessorJQW · Traditional | Cavro Scientific Instruments, Inc. | 10/29/1996SE |
| K961896 | Microlab 4000, Microlab 4200JQW · Traditional | Hamilton Co. | 08/16/1996SE |
| K961694 | ImpactJQW · Traditional | Matrix Technologies Corp. | 06/21/1996SE |
| K953345 | GenesisJQW · Traditional | Tecan U.S., Inc. | 11/21/1995SE |
More from Tecan U.S., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K873925 | Virgo(Tm) Measles Igg ElisaLJB · Traditional | 02/24/1988SE |
| K873617 | Gemstar II SystemJJE · Traditional | 10/19/1987SE |
| K873416 | Multi-Access Reagent DispenserJQW · Traditional | 10/09/1987SE |
| K873358 | Gemeni Uric Acid U.V.CDO · Traditional | 09/11/1987SE |
| K873088 | Virgo(Tm) Rubella Igg ElisaLFX · Traditional | 09/09/1987SE |
| K871905 | Toxoplasma Gondii Igg ElisaLGD · Traditional | 07/30/1987SE |
| K870928 | Cholesterol (Total) Analysis ProductsCHH · Traditional | 04/22/1987SE |
| K863874 | Lipase Hydrolysis/Glycerol Kinase, TriglyceridesCDT · Traditional | 11/13/1986SE |
| K862640 | Amylase LTSCJA · Traditional | 09/09/1986SE |
| K853372 | Gemstar Ipa Theophylline Test KitKLS · Traditional | 09/04/1985SE |
Questions and answers
When was Riause Auto Processor cleared by the FDA?
Riause Auto Processor (K801030) received a 510(k) decision of Substantially Equivalent on May 28, 1980, 27 days after the submission was received.
What is the product code of K801030?
The FDA product code is JQW – Station, Pipetting And Diluting, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2750.