FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUICKSCREEN AMPHETINE 500 TEST
K Number: K131069
·
Decision May 14, 2014
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
224
Applicant Total
15
Review Days
392
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Basic Information
- Device Name
- QUICKSCREEN AMPHETINE 500 TEST
- K Number
- K131069
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3100
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Phamatech, Inc.
- Date Received
- April 17, 2013
- Decision Date
- May 14, 2014
- Product Code
- DKZ
- 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 |
|---|---|---|---|
| DKZ | Enzyme Immunoassay, Amphetamine | FDA class 2 | Clinical Toxicology |
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Other Clearances by Phamatech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K043167 | PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X | Dec 29, 2004 | Substantially Equivalent |
| K040575 | PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112 | May 20, 2004 | Substantially Equivalent |
| K021409 | AT HOME OVULATION TEST, MODEL 9032 | May 24, 2002 | Substantially Equivalent |
| K013408 | AT HOME DRUG TEST, MODEL 9079 | Dec 6, 2001 | Substantially Equivalent |