FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, DIP-STRIP), COCAINE, METHAMPHETAMINE
K Number: K063545
·
Decision May 7, 2007
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
214
Applicant Total
43
Review Days
164
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Basic Information
- Device Name
- MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, DIP-STRIP), COCAINE, METHAMPHETAMINE
- K Number
- K063545
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 862.3650
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alfa Scientific Designs, Inc.
- Date Received
- November 24, 2006
- Decision Date
- May 7, 2007
- Product Code
- DJG
- 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 |
|---|---|---|---|
| DJG | Enzyme Immunoassay, Opiates | FDA class 2 | Clinical Toxicology |
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Other Clearances by Alfa Scientific Designs, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K173303 | INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use) | Feb 23, 2018 | Substantially Equivalent |
| K173212 | Instant-view-PLUS immunochemical Fecal Occult Blood Test | Feb 15, 2018 | Substantially Equivalent |
| K152122 | Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use) | Jun 24, 2016 | Substantially Equivalent |
| K131645 | INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE) | Oct 7, 2013 | Substantially Equivalent |
| K100051 | INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI-DRUG OF ABUSE URINE TEST (PANEL, CUP) | Jul 6, 2010 | Substantially Equivalent |
| K070660 | INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST | Jun 21, 2007 | Substantially Equivalent |
| K060527 | INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP URINE TEST; INSTANT-CONFIRMATORY BUP/NBUP URINE TEST | Jul 25, 2006 | Substantially Equivalent |
| K042227 | INSTANT-VIEW TROPONIN I TEST | Nov 19, 2004 | Substantially Equivalent |
| K024360 | INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST | Jun 10, 2003 | Substantially Equivalent |
| K022693 | INSTANT-VIEW TCA URINE TEST | Dec 9, 2002 | Substantially Equivalent |