FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROFILE II ER
K Number: K010138
·
Decision Feb 14, 2001
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
149
Applicant Total
22
Review Days
28
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Basic Information
- Device Name
- PROFILE II ER
- K Number
- K010138
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.3870
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medtox Diagnostics, Inc.
- Date Received
- January 17, 2001
- Decision Date
- February 14, 2001
- 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 Medtox Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252684 | Labcorp Fentanyl Urine Visual Test | Jan 29, 2026 | Substantially Equivalent |
| K100951 | MEDTOX BUPRENORPHINE TEST | Oct 18, 2010 | Substantially Equivalent |
| K100023 | PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEM | Apr 5, 2010 | Substantially Equivalent |
| K091454 | PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM | Jul 24, 2009 | Substantially Equivalent |
| K080635 | MEDTOXSCAN | Feb 13, 2009 | Substantially Equivalent |
| K060351 | MEDTOX OXYCODONE | May 12, 2006 | Substantially Equivalent |
| K050394 | SURE-SCREEN AMPHETAMINE, BENZODIAZEPINE, COCAINE, METHAMPHETAMINE/MDMA, METHADONE, OPIATES, PHENCYCLIDINE & CANNABINOIDS | Oct 25, 2005 | Substantially Equivalent |
| K033334 | PROFILE -ER | Nov 10, 2003 | Substantially Equivalent |
| K031032 | VERDICT II, PROFILE II | Jul 14, 2003 | Substantially Equivalent |
| K022141 | VERDICT-II | Jul 30, 2002 | Substantially Equivalent |