FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RAPIDONE-ECSTASY TEST
K Number: K013180
·
Decision Nov 26, 2001
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
30
Applicant Total
30
Review Days
63
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Basic Information
- Device Name
- RAPIDONE-ECSTASY TEST
- K Number
- K013180
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3610
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- American Bio Medica Corp.
- Date Received
- September 24, 2001
- Decision Date
- November 26, 2001
- Product Code
- DJC
- 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 |
|---|---|---|---|
| DJC | Thin Layer Chromatography, Methamphetamine | FDA class 2 | Clinical Toxicology |
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|---|---|---|---|
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| K053422 | RAPIDONE-COCAINE-150 TEST | Jun 15, 2006 | Substantially Equivalent |
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| K030835 | 'RAPID ONE' - PROPOXYPHENE TEST | May 22, 2003 | Substantially Equivalent |
| K023869 | 'RAPIDTEC'-5M-MULTIPLE DIP TEST | Apr 30, 2003 | Substantially Equivalent |
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