Axsym Amphetamine/Methamphetamine II
FDA 510(k) K953115 · Abbott Laboratories
510(k) numberK953115
Submission
- Device name
- Axsym Amphetamine/Methamphetamine II
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- July 3, 1995
- Decision date
- October 6, 1995
- 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 Axsym Amphetamine/Methamphetamine II cleared by the FDA?
Axsym Amphetamine/Methamphetamine II (K953115) received a 510(k) decision of Substantially Equivalent on October 6, 1995, 95 days after the submission was received.
What is the product code of K953115?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.