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510(k) Data Aggregation
K Number
K013124Device Name
MODIFICATION TO SCOOPER DRUG/ADULTERATION TEST CUP
Manufacturer
BRANAN MEDICAL CORP.
Date Cleared
2001-11-07
(49 days)
Product Code
DJJ, DIO, DKZ
Regulation Number
862.3640Why did this record match?
Product Code :
DJJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Scooper™ Drug/Adulterant Test Cup is an in vitro screen test for the rapid detection. The west The Scooper -- Drug/Adulterail: Test Sup Sup son and phencyclidine in human urine. The cutoff concentrations are as follows:
| OPI | Morphine | 2000 ng/m |
|-----|--------------------------------------------------|-----------|
| AMP | Amphetamines | 1000 ng/m |
| THC | 11-nor-A9-Tetrahydrocannabinol-9-carboxylic acid | 50 ng/m |
| COC | Benzoylecgonine | 300 ng/m |
| PCP | Phencyclidine | 25 ng/m |
The Scooper™ Drug/Adulteration Test Cup is used to obtain visual, qualitative results The Scooper - Drug/Additeration 2001 Super-the-counter sale to lay persons.
Device Description
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