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 | Device Class | Medical Specialty |
|---|---|---|---|
| DIF | Drug Mixture Control Materials | FDA class 1 | Clinical Toxicology |
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Other Clearances by Rapid Diagnostic Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K890030 | NEW LOW LEVEL DRUG MIXTURE CONTROL | Jan 23, 1989 | Substantially Equivalent |
| K875216 | HIGH PERFORMANCE CALIBRATORS | Jun 22, 1988 | Substantially Equivalent |
| K871694 | HYPERFORMANCE CONTROLS (HP-CONTROLS) | Jul 7, 1987 | Substantially Equivalent |
| K863117 | HIGH PERFORMANCE CANNABINOID CONTROLS | Sep 25, 1986 | Substantially Equivalent |
| K850139 | COBE COP FILTER CARDIOPULMONARY PREBYPASS FILTER | Apr 10, 1985 | Substantially Equivalent |