FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ORATECT ORAL FLUID DRUG SCREEN DEVICES
K Number: K103227
·
Decision Apr 11, 2012
Classifications
1
FEI Numbers
97
Registration Numbers
97
Same Product Code
144
Applicant Total
11
Review Days
527
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Basic Information
- Device Name
- ORATECT ORAL FLUID DRUG SCREEN DEVICES
- K Number
- K103227
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3250
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Branan Medical Corporation
- Date Received
- November 1, 2010
- Decision Date
- April 11, 2012
- Product Code
- DIO
- 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 |
|---|---|---|---|
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
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| K Number | Device Name | ||
|---|---|---|---|
| K082508 | FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD | Nov 21, 2008 | Substantially Equivalent |
| K002268 | BRANAN MEDICAL CORPORATION MONITECT MORPHINE 2000 DRUG SCREEN TEST | Nov 27, 2000 | Substantially Equivalent |
| K002264 | BRANAN MEDICAL CORPORATION MONITECT COCAINE DRUG SCREEN TEST | Nov 27, 2000 | Substantially Equivalent |
| K002342 | BRANAN MEDICAL CORPORATION MONITECT BZO DRUG SCREEN TEST | Nov 27, 2000 | Substantially Equivalent |
| K002265 | BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE DRUG SCREEN TEST | Nov 27, 2000 | Substantially Equivalent |
| K002266 | BRANAN MEDICAL CORPORATION MONITECT AMPHETAMINE DRUG SCREEN TEST | Nov 22, 2000 | Substantially Equivalent |
| K002417 | BRANAN MEDICAL CORPORATION MONITECT METHADONE DRUG SCREEN TEST, MODEL 190C AND 190D | Nov 22, 2000 | Substantially Equivalent |
| K002418 | BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AND 133D | Nov 22, 2000 | Substantially Equivalent |
| K002337 | BRANAN MEDICAL CORPORATION MONITECT BARBITURATES DRUG SCREEN TEST | Nov 22, 2000 | Substantially Equivalent |
| K002587 | BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE 500 DRUG SCREEN TEST | Nov 22, 2000 | Substantially Equivalent |