Chemtrue Multi-Panel DOA DIP Card Tests
FDA 510(k) K142580 · Chemtron Biotech, Inc.
510(k) numberK142580
Submission
- Device name
- Chemtrue Multi-Panel DOA DIP Card Tests
- Applicant
- Chemtron Biotech, Inc.
San Diego, CA, US - Received
- September 15, 2014
- Decision date
- December 1, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DKZ – Enzyme Immunoassay, Amphetamine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3100
- Specialty
- Clinical Toxicology
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| K131931 | Chemtrue(R) HCG Pregnancy Urine Midstream TestLCX · Traditional | 07/26/2013SE |
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| K121339 | Chemtrue Single/Multi-Panel Drug Screen Dip Card/Cassette TestsDKZ · Traditional | 05/17/2012SE |
| K111322 | Chemtrue Single/Multi-Panel Drug Screen Cassette/DipcardJXM · Traditional | 09/14/2011SE |
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Questions and answers
When was Chemtrue Multi-Panel DOA DIP Card Tests cleared by the FDA?
Chemtrue Multi-Panel DOA DIP Card Tests (K142580) received a 510(k) decision of Substantially Equivalent on December 1, 2014, 77 days after the submission was received.
What is the product code of K142580?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.