FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests
K Number: K153192
·
Decision Apr 18, 2016
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
214
Applicant Total
11
Review Days
167
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Basic Information
- Device Name
- Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests
- K Number
- K153192
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3650
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Chemtron Biotech, Inc.
- Date Received
- November 3, 2015
- Decision Date
- April 18, 2016
- 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 Chemtron Biotech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K232736 | Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card Test | Dec 20, 2023 | Substantially Equivalent |
| K143599 | Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000 | Apr 17, 2015 | Substantially Equivalent |
| K142580 | Chemtrue Multi-Panel DOA DIP Card Tests | Dec 1, 2014 | Substantially Equivalent |
| K142396 | Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests | Oct 9, 2014 | Substantially Equivalent |
| K131931 | CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST | Jul 26, 2013 | Substantially Equivalent |
| K123844 | CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST | May 30, 2013 | Substantially Equivalent |
| K123080 | CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTS | Nov 29, 2012 | Substantially Equivalent |
| K121339 | CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/CASSETTE TESTS | May 17, 2012 | Substantially Equivalent |
| K111322 | CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARD | Sep 14, 2011 | Substantially Equivalent |
| K102203 | CHEMTRUE SINGLE / MULTI DRUG SCREEN CASSETTE / DIP CARD TESTS | Jan 20, 2011 | Substantially Equivalent |