BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD
FDA 510(k) clearance K090109 · decided 2009-06-24
Clearance details
- K-number
- K090109
- Device name
- BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD
- Applicant
- Epocal, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-01-15
- Decision date
- 2009-06-24
- Days to decision
- 160 days
- Clearance type
- Traditional
- Product code
- CGA
- Device class
- 2
- Regulation number
- 862.1345
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Ottawa, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for recall (Z-1971-2013) | Epocal | 2013-08-14 |
| epoc Blood Analysis BGEM Test Cards for use with the epoc(R) Blood Analysis System Product recall (Z-2034-2012) | Epocal Inc | 2012-07-19 |
| 02.122.585, 85mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes recall (Z-1287-2011) | Synthes USA (HQ), Inc. | 2011-02-16 |