FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROFILE-II MODEL 600582
K Number: K982211
·
Decision Jul 29, 1998
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
11
Applicant Total
22
Review Days
36
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Basic Information
- Device Name
- PROFILE-II MODEL 600582
- K Number
- K982211
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3870
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medtox Diagnostics, Inc.
- Date Received
- June 23, 1998
- Decision Date
- July 29, 1998
- Product Code
- DKE
- 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 |
|---|---|---|---|
| DKE | Reagents, Test, Tetrahydrocannabinol | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DKE), ordered by most recent decision date.
VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II THC/COC/AMP,VERDICT II THC/COC/PCP,VERDICT II THC/COC
FDA 510(k)
FDA Class 2
·Clinical Toxicology
INSTANT-VIEW MARIJUANA URINE CASSETTE TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
STATUS STIK, ACCUSIGN STIK
FDA 510(k)
FDA Class 2
·Clinical Toxicology
STATUS CUP ACCUSIGN CUP
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA8, THC/OPI/COC/AMP/BZO/BAR/TCA/PAP, STATUS DS DO8
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/P
FDA 510(k)
FDA Class 2
·Clinical Toxicology
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| 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 |