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FDA 510(k), K955928, BARBITURATE EIA ESSAY (MODIFICATION)
FDA 510(k), K955928, BARBITURATE EIA ESSAY (MODIFICATION)
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510(K) Number: K955928
Device Name: BARBITURATE EIA ESSAY (MODIFICATION)
Manufacturer: DIAGNOSTIC REAGENTS, INC.
Device Classification Name: enzyme immunoassay, barbiturate
Regulation Number: 862.3150
Classification Product Code: DIS
Date Received: 12/18/1995
Decision Date: 03/11/1996
Regulation Medical Specialty: Toxicology
Device Name: BARBITURATE EIA ESSAY (MODIFICATION)
Manufacturer: DIAGNOSTIC REAGENTS, INC.
Device Classification Name: enzyme immunoassay, barbiturate
Regulation Number: 862.3150
Classification Product Code: DIS
Date Received: 12/18/1995
Decision Date: 03/11/1996
Regulation Medical Specialty: Toxicology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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