Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000— 510(k) K143599
Substantially EquivalentChemtron Biotech, Inc.
FDA 510(k) clearance K143599 for Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000, Substantially Equivalent on 2015-04-17. Applicant: Chemtron Biotech, Inc.. Device class: 2.
Clearance details
- Applicant
- Chemtron Biotech, Inc.
- Product code
- Code DJG
- Device class
- Class 2
- Regulation
- 21 CFR 862.3650
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code DJG
view allMore clearances from Chemtron Biotech, Inc.
view all- 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
- K153192 — Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests
- K142580 — Chemtrue Multi-Panel DOA DIP Card Tests
- K142396 — Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests
- K131931 — CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.