FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RAPIDONE - MARIJUANA TEST
K Number: K990818
·
Decision Jul 7, 1999
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
149
Applicant Total
30
Review Days
118
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Basic Information
- Device Name
- RAPIDONE - MARIJUANA TEST
- K Number
- K990818
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3870
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- American Bio Medica Corp.
- Date Received
- March 11, 1999
- Decision Date
- July 7, 1999
- 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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Other Clearances by American Bio Medica Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K170222 | Rapid Tox Cup II | Aug 15, 2017 | Substantially Equivalent |
| K073078 | RAPID TOX CUP | May 30, 2008 | Substantially Equivalent |
| K060760 | RAPIDONE-BUPRENORPHINE TEST | Aug 7, 2006 | Substantially Equivalent |
| K053422 | RAPIDONE-COCAINE-150 TEST | Jun 15, 2006 | Substantially Equivalent |
| K053359 | RAPIDTOX | May 25, 2006 | Substantially Equivalent |
| K041696 | RAPID READER | Jul 12, 2005 | Substantially Equivalent |
| K041712 | 'RAPIDTEC 4' TEST | Nov 3, 2004 | Substantially Equivalent |
| K030835 | 'RAPID ONE' - PROPOXYPHENE TEST | May 22, 2003 | Substantially Equivalent |
| K023869 | 'RAPIDTEC'-5M-MULTIPLE DIP TEST | Apr 30, 2003 | Substantially Equivalent |
| K021114 | 'RAPIDTEC' 5A MULTIPLE DIP TEST | Jul 23, 2002 | Substantially Equivalent |