FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE)
K Number: K131645
·
Decision Oct 7, 2013
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
224
Applicant Total
43
Review Days
124
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE)
- K Number
- K131645
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 862.3100
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alfa Scientific Designs, Inc.
- Date Received
- June 5, 2013
- Decision Date
- October 7, 2013
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DKZ), ordered by most recent decision date.
DRI Ecstasy Plus Assay
FDA 510(k)
FDA Class 2
·Clinical Toxicology
AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Xenta Drug Screen Cup, Xenta Drug Screen Dipcard
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Quidel Triage® TOX Drug Screen, 94600
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro
FDA 510(k)
FDA Class 2
·Clinical Toxicology
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 |
| 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 |
| K063545 | MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, DIP-STRIP), COCAINE, METHAMPHETAMINE | May 7, 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 |