FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UCP COMPACT DRUG TESTS
K Number: K152908
·
Decision May 3, 2016
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
224
Applicant Total
14
Review Days
215
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Basic Information
- Device Name
- UCP COMPACT DRUG TESTS
- K Number
- K152908
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3100
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ucp Biosciences, Inc.
- Date Received
- October 1, 2015
- Decision Date
- May 3, 2016
- 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 Ucp Biosciences, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K151213 | UCP Drug Test Mini Cups | Aug 21, 2015 | Substantially Equivalent |
| K132812 | UCP MULTI-DRUG TEST KEY CUPS | Mar 6, 2014 | Substantially Equivalent |
| K131236 | UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY CASSETTE TEST, MIDSTREAM TEST AND DIP/CARD STRIP | Nov 7, 2013 | Substantially Equivalent |
| K131811 | UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS | Jul 19, 2013 | Substantially Equivalent |
| K130463 | UCP HOME DRUG SCREENING TEST; CARDS, CUPS | May 15, 2013 | Substantially Equivalent |
| K123863 | UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS | Jan 9, 2013 | Substantially Equivalent |
| K122419 | UCP HOME DRUG SCREENING TEST CUPS | Nov 30, 2012 | Substantially Equivalent |
| K110515 | UCP DRUG SCREENING TEST CUPS | Apr 20, 2011 | Substantially Equivalent |
| K091612 | UCP RAPID DRUG SCREENING BUPRENORPHINE, AMP 300, MAMP 500, COC 150 TEST; | Feb 24, 2010 | Substantially Equivalent |
| K091588 | UCP HOME DRUG SCREENING TESTS | Sep 4, 2009 | Substantially Equivalent |