Synchron Systems Amphetamine Reagent
FDA 510(k) K000606 · Beckman Coulter, Inc.
510(k) numberK000606
Submission
- Device name
- Synchron Systems Amphetamine Reagent
- Applicant
- Beckman Coulter, Inc.
Brea, CA, US - Received
- February 23, 2000
- Decision date
- May 5, 2000
- 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 Synchron Systems Amphetamine Reagent cleared by the FDA?
Synchron Systems Amphetamine Reagent (K000606) received a 510(k) decision of Substantially Equivalent on May 5, 2000, 72 days after the submission was received.
What is the product code of K000606?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.