Chemtrue Multi-Panel DOA DIP Card Tests— 510(k) K142580
Substantially EquivalentChemtron Biotech, Inc.
FDA 510(k) clearance K142580 for Chemtrue Multi-Panel DOA DIP Card Tests, Substantially Equivalent on 2014-12-01. Applicant: Chemtron Biotech, Inc.. Device class: 2.
Clearance details
- Applicant
- Chemtron Biotech, Inc.
- Product code
- Code DKZ
- Device class
- Class 2
- Regulation
- 21 CFR 862.3100
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Diego, CA, US
Recent devices under product code DKZ
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- K143599 — Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000
- K142396 — Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests
- K131931 — CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST
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