510(k) K051968
- Device
- ABL8X7 FLEX
- Applicant
- RADIOMETER MEDICAL APS
- 510(k) number
- K051968
- Product code
- CGL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-10-16
- Date received
- 2005-07-20
- Regulation
- 862.1225
- Classification name
- Electrode, Ion Based, Enzymatic, Creatinine
- 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
- LENE MEINECHE MARNAES
- Address
- Akandevej 21 Dk-2700 Bronshoj DK
FDA Registration Numbers#
- 3005643513
- 3004193489
- 3023162659
- 3012817228
- 2245578
- 3002807968
- 3007490412
- 3013513377
- 3006198300
- 1219029
- 3004959793
- 3011979858
Source Documents#
Other 510(k) Records For Product Code CGL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K171059 | Nova StatSensor Creatinine Hospital Meter System | Nova Biomedical Corporation | 2017-05-26 |
| K113726 | EPOC CHLORIDE TEST AND EPOC CREATININE TEST | Epocal, Inc. | 2012-10-05 |
| K070068 | NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS | Nova Biomedical Corp. | 2007-05-07 |
| K991727 | STAT PROFILE M7 ANALYZER | Nova Biomedical Corp. | 1999-07-16 |
| K973292 | I-STAT SYSTEM | I-Stat Corp. | 1997-10-20 |
| K903034 | RENALYZER PRX 90 | Swedish Trade Council USA | 1991-03-13 |
Legacy Summary#
summary
FDA Review#
Decision Summary