FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VERDICT -II METHAMPHETAMINE
K Number: K010226
·
Decision Jun 1, 2001
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
30
Applicant Total
22
Review Days
128
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- VERDICT -II METHAMPHETAMINE
- K Number
- K010226
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3610
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medtox Diagnostics, Inc.
- Date Received
- January 24, 2001
- Decision Date
- June 1, 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DJC), ordered by most recent decision date.
Healgen® Accurate Oral Fluid Drug Test
FDA 510(k)
FDA Class 2
·Clinical Toxicology
LYHER® Oral fluid Multi-Drug Test Kit (Cube)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use, BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx
FDA 510(k)
FDA Class 2
·Clinical Toxicology
OralTox Oral fluid Drug Test
FDA 510(k)
FDA Class 2
·Clinical Toxicology
OralTox Oral Fluid Drug Test
FDA 510(k)
FDA Class 2
·Clinical Toxicology
AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
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 |