Ontrak Testcup M2K, Model Cat. 11 1849 8
FDA 510(k) K990399 · Roche Diagnostics Corp.
510(k) numberK990399
Submission
- Device name
- Ontrak Testcup M2K, Model Cat. 11 1849 8
- Applicant
- Roche Diagnostics Corp.
Indianapolis, IN, US - Received
- February 9, 1999
- Decision date
- April 15, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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Questions and answers
When was Ontrak Testcup M2K, Model Cat. 11 1849 8 cleared by the FDA?
Ontrak Testcup M2K, Model Cat. 11 1849 8 (K990399) received a 510(k) decision of Substantially Equivalent on April 15, 1999, 65 days after the submission was received.
What is the product code of K990399?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.