Ontrak Testcup PRO-5, Model 1986678
FDA 510(k) K001356 · Roche Diagnostics Corp.
510(k) numberK001356
Submission
- Device name
- Ontrak Testcup PRO-5, Model 1986678
- Applicant
- Roche Diagnostics Corp.
Indianapolis, IN, US - Received
- April 28, 2000
- Decision date
- July 10, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DJC – Thin Layer Chromatography, Methamphetamine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3610
- Specialty
- Clinical Toxicology
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| K060355 | Acro Biotech LLC Rapid Mdma Urine Test, Catalog MDMA0010000DJC · Traditional | Acro Biotech, LLC | 08/07/2006SE |
| K060896 | Modification to Ontrak Testcup II and Onsite CupkitDJC · Traditional | Varian, Inc. | 06/09/2006SE |
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Questions and answers
When was Ontrak Testcup PRO-5, Model 1986678 cleared by the FDA?
Ontrak Testcup PRO-5, Model 1986678 (K001356) received a 510(k) decision of Substantially Equivalent on July 10, 2000, 73 days after the submission was received.
What is the product code of K001356?
The FDA product code is DJC – Thin Layer Chromatography, Methamphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3610.