FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICE
K Number: K010841
·
Decision Jul 9, 2001
Classifications
1
FEI Numbers
97
Registration Numbers
97
Same Product Code
144
Applicant Total
85
Review Days
110
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Basic Information
- Device Name
- ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICE
- K Number
- K010841
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3250
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ACON Laboratories, Inc.
- Date Received
- March 21, 2001
- Decision Date
- July 9, 2001
- Product Code
- DIO
- 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 |
|---|---|---|---|
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | FDA class 2 | Clinical Toxicology |
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