RAICHEM CALCIUM (OCPC) LIQUID REAGENT
FDA 510(k) clearance K041009 · decided 2004-06-25
Clearance details
- K-number
- K041009
- Device name
- RAICHEM CALCIUM (OCPC) LIQUID REAGENT
- Applicant
- Hemagen Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-04-19
- Decision date
- 2004-06-25
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- CIC
- Device class
- 2
- Regulation number
- 862.1145
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Columbia, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Roche Calcium Reagent Kit for use on the Cobas MIRA Chemistry System; in vitro diagnostic; recall (Z-1176-06) | Roche Diagnostics Corp. | 2006-06-27 |