FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BRANAN MEDICAL CORPORATION MONITECT BZO DRUG SCREEN TEST
K Number: K002342
·
Decision Nov 27, 2000
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
89
Applicant Total
11
Review Days
118
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Basic Information
- Device Name
- BRANAN MEDICAL CORPORATION MONITECT BZO DRUG SCREEN TEST
- K Number
- K002342
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3170
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Branan Medical Corporation
- Date Received
- August 1, 2000
- Decision Date
- November 27, 2000
- Product Code
- JXM
- 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 |
|---|---|---|---|
| JXM | Enzyme Immunoassay, Benzodiazepine | FDA class 2 | Clinical Toxicology |
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|---|---|---|---|
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| K002264 | BRANAN MEDICAL CORPORATION MONITECT COCAINE DRUG SCREEN TEST | Nov 27, 2000 | Substantially Equivalent |
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| 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 |