FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QuickScreen Pro Multi Drug Screening Test, Model 9395Z
K Number: K181945
·
Decision Oct 18, 2018
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
224
Applicant Total
15
Review Days
90
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Basic Information
- Device Name
- QuickScreen Pro Multi Drug Screening Test, Model 9395Z
- K Number
- K181945
- 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
- July 20, 2018
- Decision Date
- October 18, 2018
- 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 | ||
|---|---|---|---|
| K131069 | QUICKSCREEN AMPHETINE 500 TEST | May 14, 2014 | Substantially Equivalent |
| K103295 | QUICKSCREEN COCAINE 150 SCREENING TEST | Feb 1, 2012 | Substantially Equivalent |
| K070009 | AT HOME DRUG TEST MODELS, 9308T AND 9308X | Dec 7, 2007 | Substantially Equivalent |
| K070098 | QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREENING TEST, MODEL 9317T; CUP MULTI DRUG SC | Dec 7, 2007 | Substantially Equivalent |
| K043599 | MOMENTS MENOPAUSE CHECK, MODEL 9113 | Feb 25, 2005 | Substantially Equivalent |
| K043051 | QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121 | Feb 7, 2005 | Substantially Equivalent |
| 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 |