FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY CASSETTE TEST, MIDSTREAM TEST AND DIP/CARD STRIP
K Number: K131236
·
Decision Nov 7, 2013
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
225
Applicant Total
14
Review Days
190
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
- UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY CASSETTE TEST, MIDSTREAM TEST AND DIP/CARD STRIP
- K Number
- K131236
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ucp Biosciences, Inc.
- Date Received
- May 1, 2013
- Decision Date
- November 7, 2013
- Product Code
- LCX
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LCX), ordered by most recent decision date.
MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Shinetell PlusTM Digital Early Pregnancy Test
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream
FDA 510(k)
FDA Class 2
·Clinical Chemistry
iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Ucp Biosciences, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K152908 | UCP COMPACT DRUG TESTS | May 3, 2016 | Substantially Equivalent |
| K151213 | UCP Drug Test Mini Cups | Aug 21, 2015 | Substantially Equivalent |
| K132812 | UCP MULTI-DRUG TEST KEY CUPS | Mar 6, 2014 | 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 |