Ontrak Testcup 501, Model 3016633
FDA 510(k) K001421 · Roche Diagnostics Corp.
510(k) numberK001421
Submission
- Device name
- Ontrak Testcup 501, Model 3016633
- Applicant
- Roche Diagnostics Corp.
Indianapolis, IN, US - Received
- May 5, 2000
- Decision date
- July 12, 2000
- 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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Questions and answers
When was Ontrak Testcup 501, Model 3016633 cleared by the FDA?
Ontrak Testcup 501, Model 3016633 (K001421) received a 510(k) decision of Substantially Equivalent on July 12, 2000, 68 days after the submission was received.
What is the product code of K001421?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.