One Step Drug Test - Amp/Met/Mor/Thc/Coc
FDA 510(k) K060810 · Ind Diagnostic, Inc.
510(k) numberK060810
Submission
- Device name
- One Step Drug Test - Amp/Met/Mor/Thc/Coc
- Applicant
- Ind Diagnostic, Inc.
Delta, B.C., CA - Received
- March 24, 2006
- Decision date
- August 7, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 One Step Drug Test - Amp/Met/Mor/Thc/Coc cleared by the FDA?
One Step Drug Test - Amp/Met/Mor/Thc/Coc (K060810) received a 510(k) decision of Substantially Equivalent on August 7, 2006, 136 days after the submission was received.
What is the product code of K060810?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.