Gambro DQM 200
FDA 510(k) K990039 · Gambro Healthcare
510(k) numberK990039
Submission
- Device name
- Gambro DQM 200
- Applicant
- Gambro Healthcare
Lakewood, CO, US - Received
- January 6, 1999
- Decision date
- January 27, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LFP – Conductivity Rate, Urea Nitrogen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1770
- Specialty
- Clinical Chemistry
Other 510(k)s with product code LFP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K992847 | Hichem Bun ReagentLFP · Traditional | Elan Holdings, Inc. | 10/14/1999SE |
| K963537 | Sigma Diagnostics Bun ReagentLFP · Traditional | Sigma Diagnostics, Inc. | 10/24/1996SE |
| K933679 | Sigma Bun ReagentLFP · Traditional | Sigma Chemical Co. | 12/17/1993SE |
| K873132 | Bun Reagent KitLFP · Traditional | A-Kem, Inc. | 10/23/1987SE |
| K812945 | Liquilyme Bun ReagentLFP · Traditional | Amresco, Inc. | 11/06/1981SE |
More from Amresco, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K994390 | Gambro Polyflux 17R, Capillary Dialyzer/ FilterMSF · Traditional | 10/26/2000SE |
| K982413 | Cobe Arylane H1, H4, H6 & H9 Hemodialyzers/FiltersKDI · Traditional | 04/21/1999SE |
| K982414 | Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ HemofiltersKDI · Traditional | 03/26/1999SE |
| K980386 | Hospal Multiflow 100, Multiflow 100 Kits A0 (A0,A0/B and A0/0), Multiflow 100 Kits B22…KDI · Traditional | 02/24/1999SE |
| K982760 | Cobe C Hemodialysis Delivery System , Cobe Cartridge Blood Tubing SetKDI · Traditional | 11/04/1998SE |
| K982818 | Hospal TipstopKMF · Traditional | 10/21/1998SE |
| K974899 | Gambro Central Water Treatment System CWP 100 - Wro HFIP · Traditional | 09/23/1998SE |
| K981681 | Prisma CFM (Continuous Fluid Management System)KDI · Traditional | 08/11/1998SE |
| K981085 | Gambro Hemodialysis Water Treatment SystemFIP · Traditional | 05/18/1998SE |
| K970253 | Cobe Centrysystem 3 Dialysis Control Unit/Cobe Cartridge Blood Tubing SetKDI · Traditional | 09/26/1997SE |
Questions and answers
When was Gambro DQM 200 cleared by the FDA?
Gambro DQM 200 (K990039) received a 510(k) decision of Substantially Equivalent on January 27, 2000, 386 days after the submission was received.
What is the product code of K990039?
The FDA product code is LFP – Conductivity Rate, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.