FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

BLIND CONTROLS FOR DRUGS OF ABUSE TESTING

K Number: K903909 · Decision Oct 26, 1990
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
201
Applicant Total
6
Review Days
65

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Basic Information

Device Name
BLIND CONTROLS FOR DRUGS OF ABUSE TESTING
K Number
K903909
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
862.3280
Medical Specialty
Clinical Toxicology
Decision
Substantially Equivalent
Applicant
Rapid Diagnostic Laboratories, Inc.
Date Received
August 22, 1990
Decision Date
October 26, 1990
Product Code
DIF
Advisory Committee
Clinical Toxicology
Review Advisory Committee
TX
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
DIF Drug Mixture Control Materials

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Other Clearances by Rapid Diagnostic Laboratories, Inc.

K Number Device Name
K890030 NEW LOW LEVEL DRUG MIXTURE CONTROL
K875216 HIGH PERFORMANCE CALIBRATORS
K871694 HYPERFORMANCE CONTROLS (HP-CONTROLS)
K863117 HIGH PERFORMANCE CANNABINOID CONTROLS
K850139 COBE COP FILTER CARDIOPULMONARY PREBYPASS FILTER