LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC
FDA 510(k) clearance K072721 · decided 2007-12-11
Clearance details
- K-number
- K072721
- Device name
- LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC
- Applicant
- Bio-Rad, Diagnostics Grp.
- Decision
- Substantially Equivalent
- Date received
- 2007-09-26
- Decision date
- 2007-12-11
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- DIF
- Device class
- 1
- Regulation number
- 862.3280
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|
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| DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL (K121122) | Biochemical Diagnostic, Inc. | 2012-07-03 |
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| THERMO SCIENTIFIC MAS R DOA TOTAL (K103656) | Microgenics Corporation | 2011-03-24 |
| LIQUICHEK OPIATE CONTROL (K093577) | Bio-Rad Laboratories | 2010-03-12 |
| MAS TOX CONTROL (K080085) | Thermo Fisher Scientific | 2008-04-30 |
| CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500 (K080183) | Roche Diagnostics Corp. | 2008-03-25 |
| ESA LEADCARE II LEAD CONTROL (K063398) | Bionostics, Inc. | 2006-12-05 |
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Recalls involving this device
No recalls on record reference this clearance.