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FDA 510(k), K001976, STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I
FDA 510(k), K001976, STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I
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510(K) Number: K001976
Device Name: STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I
Manufacturer: R. SAM NIEDBALA
Device Classification Name: Enzyme Immunoassay, Barbiturate
Regulation Number: DIS
Classification Product Code: KXA
Date Received: 06/29/2000
Decision Date: 12/06/2000
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Toxicology
Device Name: STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I
Manufacturer: R. SAM NIEDBALA
Device Classification Name: Enzyme Immunoassay, Barbiturate
Regulation Number: DIS
Classification Product Code: KXA
Date Received: 06/29/2000
Decision Date: 12/06/2000
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Toxicology
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