510(k) K990039
- Device
- GAMBRO DQM 200
- Applicant
- GAMBRO HEALTHCARE
- 510(k) number
- K990039
- Product code
- LFP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-01-27
- Date received
- 1999-01-06
- Regulation
- 862.1770
- Classification name
- Conductivity Rate, Urea Nitrogen
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JEFFREY R SHIDEMAN
- Address
- 1185 Oak St. Lakewood CO US 80215 80215
FDA Registration Numbers#
- 3011989923
- 2050010
- 2050012
- 9680746
Source Documents#
Other 510(k) Records For Product Code LFP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K992847 | HICHEM BUN REAGENT | Elan Holdings, Inc. | 1999-10-14 |
| K963537 | SIGMA DIAGNOSTICS BUN REAGENT | Sigma Diagnostics, Inc. | 1996-10-24 |
| K933679 | SIGMA BUN REAGENT | Sigma Chemical Co. | 1993-12-17 |
| K873132 | BUN REAGENT KIT | A-Kem, Inc. | 1987-10-23 |
| K812945 | LIQUILYME BUN REAGENT | Amresco, Inc. | 1981-11-06 |
Legacy Summary#
summary
FDA Review#
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