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CLIA record K034069 and corresponding 510(K) Premarket Notification information
Test System Name | Roche Diagnostics Hitachi 917 {Microgenics CEDIA Sirolimus Assay} |
Document Number |
K034069 |
Analyte Name | sirolimus |
Analyte Specialty | Toxicology / TDM |
Complexity | HIGH |
Effective Date | 05/03/2005 |
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510(k) Premarket Notification Database
Device Classification Name |
sirolimus test system
|
510(k) Number | K034069 |
Device Name | CEDIA SIROLIMUS ASSAY |
Applicant |
MICROGENICS CORP.
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46360 fremont blvd. |
fremont,
CA
94538 |
|
Contact | david casal |
Regulation Number | 862.3840 |
Classification Product Code |
|
Date Received | 01/06/2004 |
Decision Date | 06/15/2004 |
Decision |
cleared for marketing automatic class iii designat (AN) |
Classification Advisory Committee |
Toxicology
|
Review Advisory Committee |
Clinical Chemistry
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FOI ITEM |
LETTER
|
Type |
Cleared for Marketing Automatic Class III Designation
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Reviewed by Third Party |
No
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Expedited Review |
No
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