Online Dat II Cannabinoids II
FDA 510(k) K030213 · Roche Diagnostics Corp.
510(k) numberK030213
Submission
- Device name
- Online Dat II Cannabinoids II
- Applicant
- Roche Diagnostics Corp.
Indianapolis, IN, US - Received
- January 21, 2003
- Decision date
- April 11, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LDJ – Enzyme Immunoassay, Cannabinoids
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3870
- Specialty
- Clinical Toxicology
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Questions and answers
When was Online Dat II Cannabinoids II cleared by the FDA?
Online Dat II Cannabinoids II (K030213) received a 510(k) decision of Substantially Equivalent on April 11, 2003, 80 days after the submission was received.
What is the product code of K030213?
The FDA product code is LDJ – Enzyme Immunoassay, Cannabinoids, a Class II (moderate risk) device regulated under 21 CFR 862.3870.