FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/CASSETTE TESTS
K Number: K121339
·
Decision May 17, 2012
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
224
Applicant Total
11
Review Days
14
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
- CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/CASSETTE TESTS
- K Number
- K121339
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3100
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Chemtron Biotech, Inc.
- Date Received
- May 3, 2012
- Decision Date
- May 17, 2012
- 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 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 |
| K153192 | Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests | Apr 18, 2016 | 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 |
| 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 |