Model 90 BC
FDA 510(k) K821415 · Western Laboratories Corp.
510(k) numberK821415
Submission
- Device name
- Model 90 BC
- Applicant
- Western Laboratories Corp.
Mchenry, IL, US - Received
- May 12, 1982
- Decision date
- May 27, 1982
- 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 |
| K882032 | Model 90DX Multitest MeterFLB · Traditional | Mesa Medical, Inc. | 08/11/1988SE |
| K830629 | Cobe RX MeterFLB · Traditional | Cobe Laboratories, Inc. | 04/06/1983SE |
| K770263 | Dialysate Meter RS-2100A, Circuit ChangeFLB · Traditional | Renal Systems, Inc. | 02/18/1977SE |
More from Renal Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K834024 | HeparinometerKFF · Traditional | 06/11/1984SE |
| K830468 | Model 200FTZ · Traditional | 04/12/1983SE |
| K821834 | Model 100 Bicarbonate ConductivityFKQ · Traditional | 07/02/1982SE |
| K821414 | Model 80 BC · Traditional | 05/27/1982SE |
| K801303 | Model 90 Pressure/Conductivity/Temp TestKDI · Traditional | 07/28/1980SE |
| K780932 | Model 80 Conductivity/Temp.Test UnitFIZ · Traditional | 08/31/1978SE |
Questions and answers
When was Model 90 BC cleared by the FDA?
Model 90 BC (K821415) received a 510(k) decision of Substantially Equivalent on May 27, 1982, 15 days after the submission was received.
What is the product code of K821415?
The FDA product code is FLB – Meter, Conductivity, Induction, Remote Type, a Class II (moderate risk) device regulated under 21 CFR 876.5820.