FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X
K Number: K043167
·
Decision Dec 29, 2004
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
89
Applicant Total
15
Review Days
43
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Basic Information
- Device Name
- PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X
- K Number
- K043167
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.3170
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Phamatech, Inc.
- Date Received
- November 16, 2004
- Decision Date
- December 29, 2004
- Product Code
- JXM
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- CH
- 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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