Roche Oral Fluid Amphetamine, Roche Oral Fluid Dat Qual Cal B, Roche Oral Fluid Dat Control Set B, and Roche Oral Fluid
FDA 510(k) K110446 · Roche Diagnostics
510(k) numberK110446
Submission
- Device name
- Roche Oral Fluid Amphetamine, Roche Oral Fluid Dat Qual Cal B, Roche Oral Fluid Dat Control Set B, and Roche Oral Fluid
- Applicant
- Roche Diagnostics
Indianapolis, IN, US - Received
- February 16, 2011
- Decision date
- May 3, 2011
- 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 Roche Oral Fluid Amphetamine, Roche Oral Fluid Dat Qual Cal B, Roche Oral Fluid Dat Control Set B, and Roche Oral Fluid cleared by the FDA?
Roche Oral Fluid Amphetamine, Roche Oral Fluid Dat Qual Cal B, Roche Oral Fluid Dat Control Set B, and Roche Oral Fluid (K110446) received a 510(k) decision of Substantially Equivalent on May 3, 2011, 76 days after the submission was received.
What is the product code of K110446?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.