Model 90DX Multitest Meter
FDA 510(k) K882032 · Mesa Medical, Inc.
510(k) numberK882032
Submission
- Device name
- Model 90DX Multitest Meter
- Applicant
- Mesa Medical, Inc.
Wheat Ridge, CO, US - Received
- May 16, 1988
- Decision date
- August 11, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FLB – Meter, Conductivity, Induction, Remote Type
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FLB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K100237 | Dialysate Meter, Model D-6FLB · Traditional | Myron L Company | 04/23/2010SE |
| K925210 | 90DX Multitest Meter, ModificationFLB · Traditional | Mesa Medical, Inc. | 01/25/1994SE |
| K830629 | Cobe RX MeterFLB · Traditional | Cobe Laboratories, Inc. | 04/06/1983SE |
| K821415 | Model 90 BCFLB · Traditional | Western Laboratories Corp. | 05/27/1982SE |
| K770263 | Dialysate Meter RS-2100A, Circuit ChangeFLB · Traditional | Renal Systems, Inc. | 02/18/1977SE |
More from Renal Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K925210 | 90DX Multitest Meter, ModificationFLB · Traditional | 01/25/1994SE |
| K870811 | Model 102 PH MeterLRI · Traditional | 03/24/1987SE |
| K852749 | Recommended Alternative Dialyzer DisinfectantFKQ · Traditional | 09/10/1985SE |
| K843520 | Warexin Recommended Alternative DialyzLIF · Traditional | 10/04/1984SE |
| K834447 | Echo MM1000LIF · Traditional | 03/23/1984SE |
| K821383 | Echo, Model MM-1000LIF · Traditional | 06/23/1982SE |
Questions and answers
When was Model 90DX Multitest Meter cleared by the FDA?
Model 90DX Multitest Meter (K882032) received a 510(k) decision of Substantially Equivalent on August 11, 1988, 87 days after the submission was received.
What is the product code of K882032?
The FDA product code is FLB – Meter, Conductivity, Induction, Remote Type, a Class II (moderate risk) device regulated under 21 CFR 876.5820.