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

HIGH PERFORMANCE CANNABINOID CONTROLS

K Number: K863117 · Decision Sep 25, 1986
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
82
Applicant Total
6
Review Days
42

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Basic Information

Device Name
HIGH PERFORMANCE CANNABINOID CONTROLS
K Number
K863117
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 14, 1986
Decision Date
September 25, 1986
Product Code
LAS
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
LAS Drug Specific Control Materials

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Other Clearances by Rapid Diagnostic Laboratories, Inc.

K Number Device Name
K903909 BLIND CONTROLS FOR DRUGS OF ABUSE TESTING
K890030 NEW LOW LEVEL DRUG MIXTURE CONTROL
K875216 HIGH PERFORMANCE CALIBRATORS
K871694 HYPERFORMANCE CONTROLS (HP-CONTROLS)
K850139 COBE COP FILTER CARDIOPULMONARY PREBYPASS FILTER