FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ON CALL HOME DRUG TEST FOR MARIJUANA AND ON CALL HOME DRUG TEST FOR MARIJUANA AND COCAINE
K Number: K050936
·
Decision Jun 24, 2005
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
149
Applicant Total
85
Review Days
71
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Basic Information
- Device Name
- ON CALL HOME DRUG TEST FOR MARIJUANA AND ON CALL HOME DRUG TEST FOR MARIJUANA AND COCAINE
- K Number
- K050936
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3870
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ACON Laboratories, Inc.
- Date Received
- April 14, 2005
- Decision Date
- June 24, 2005
- Product Code
- LDJ
- 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 |
|---|---|---|---|
| LDJ | Enzyme Immunoassay, Cannabinoids | FDA class 2 | Clinical Toxicology |
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