FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RAPID TOX CUP
K Number: K073078
·
Decision May 30, 2008
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
3
Applicant Total
30
Review Days
212
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Basic Information
- Device Name
- RAPID TOX CUP
- K Number
- K073078
- 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
- October 31, 2007
- Decision Date
- May 30, 2008
- Product Code
- LAG
- 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 |
|---|---|---|---|
| LAG | High Pressure Liquid Chromatography, Methamphetamine | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LAG), ordered by most recent decision date.
MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP, BIOSIGN DOA10, BIOSIGN MET/OPI/
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ACCUSIGN DOA 10,ACCUSIGN DOA PANEL,ACCUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP,BIOSIGN DOA 10, BIOSIGN MET/OPI/COC/
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Other Clearances by American Bio Medica Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K170222 | Rapid Tox Cup II | Aug 15, 2017 | 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 |
| K014101 | RAPIDONE-OXY TEST | Mar 20, 2002 | Substantially Equivalent |