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510(k) Data Aggregation
K Number
K011275Device Name
PSYCHEMEDICS RIA PHENCYCLIDINE ASSAY
Manufacturer
PSYCHEMEDICS CORP.
Date Cleared
2002-02-11
(291 days)
Product Code
LCL
Regulation Number
N/AWhy did this record match?
Product Code :
LCL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K994093Device Name
AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25C
Manufacturer
PHAMATECH
Date Cleared
1999-12-16
(13 days)
Product Code
LCL, DIO, DJG, DKZ, LDJ
Regulation Number
N/AWhy did this record match?
Product Code :
LCL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A workplace drug screening and confirmation service. This kit provides a preliminary result for the detection/presence of the following drugs of abuse in urine: Phencyclidine (PCP), Amphetamine, THC (marijuana), Cocaine and Opiates.
Device Description
At Work Drug Test is a rapid, qualitative immunoassay for the detection of the target drugs/drug metabolites in urine. The cut-off concentrations of this test are as follows: Phencyclidine (PCP); 25 ng/ml, amphetamine; 1000 ng/ml, cocaine; 300 ng/ml and opiates; #9145 25C at 300 ng/ml and 9177 25C at 2000 ng/ml. This assay is intended for use in the workplace assist in the prevention of drug abuse. This kit, as supplied, incorporates a mechanism for confirmation testing by GC/MS, to be performed at a certified laboratory. The At Work Drug Test, like many commercially available drug screening test kits, qualitatively measures the presence of target drugs or their metabolites by visual color sandwich one step immunoassay technology.
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