Cedia Dau Amphassure Assay
FDA 510(k) K994380 · Microgenics Corp.
510(k) numberK994380
Submission
- Device name
- Cedia Dau Amphassure Assay
- Applicant
- Microgenics Corp.
Fremont Blvd., CA, US - Received
- December 27, 1999
- Decision date
- May 2, 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 Cedia Dau Amphassure Assay cleared by the FDA?
Cedia Dau Amphassure Assay (K994380) received a 510(k) decision of Substantially Equivalent on May 2, 2000, 127 days after the submission was received.
What is the product code of K994380?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.