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FDA 510(k), K040316, CEDIA BUPRENORPHINE ASSAY
FDA 510(k), K040316, CEDIA BUPRENORPHINE ASSAY
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510(K) Number: K040316
Device Name: CEDIA BUPRENORPHINE ASSAY
Manufacturer: MICROGENICS CORP.
Device Classification Name: enzyme immunoassay, opiates
Regulation Number: 862.3650
Classification Product Code: DJG
Date Received: 02/09/2004
Decision Date: 06/23/2004
Regulation Medical Specialty: Toxicology
Device Name: CEDIA BUPRENORPHINE ASSAY
Manufacturer: MICROGENICS CORP.
Device Classification Name: enzyme immunoassay, opiates
Regulation Number: 862.3650
Classification Product Code: DJG
Date Received: 02/09/2004
Decision Date: 06/23/2004
Regulation Medical Specialty: Toxicology
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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