FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE STEP METHAMPHETAMINE TEST DEVICE
K Number: K011672
·
Decision Jul 31, 2001
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
48
Applicant Total
85
Review Days
62
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Basic Information
- Device Name
- ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE STEP METHAMPHETAMINE TEST DEVICE
- K Number
- K011672
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3610
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ACON Laboratories, Inc.
- Date Received
- May 30, 2001
- Decision Date
- July 31, 2001
- Product Code
- LAF
- 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 |
|---|---|---|---|
| LAF | Gas Chromatography, Methamphetamine | FDA class 2 | Clinical Toxicology |
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