510(k) K841575
- Device
- SENTECH'S ULAB 1000 CLINICAL CHEM.
- Applicant
- SENTECH MEDICAL CORP.
- 510(k) number
- K841575
- Product code
- CEM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-07-06
- Date received
- 1984-04-17
- Regulation
- 862.1600
- Classification name
- Electrode, Ion Specific, Potassium
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Clearance type
- Traditional
- Third party reviewed
- No
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|---|---|---|---|
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| K112412 | AU5800(R) CHEMISTRY ANALYZER | Beckman Coulter, Inc. | 2011-12-23 |
| K112408 | POLY-CHEM 90 ISE MODULE | Polymedco, Inc. | 2011-11-04 |
| K112788 | EASTLYTE NA/K/CA/PH | Medica Corp. | 2011-10-20 |
| K092686 | ABL90 FLEX SERIES | Radiometer Medical Aps | 2010-08-06 |
| K092849 | BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER | Epocal, Inc. | 2010-03-30 |
| K093318 | ACCELERATOR APS | Abbott Laboratories | 2010-02-19 |
Legacy Summary#
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FDA Review#
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