Cedia Dau Opiate Assay
FDA 510(k) K941195 · Microgenics Corp.
510(k) numberK941195
Submission
- Device name
- Cedia Dau Opiate Assay
- Applicant
- Microgenics Corp.
Concord, CA, US - Received
- March 14, 1994
- Decision date
- September 7, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DJG – Enzyme Immunoassay, Opiates
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3650
- Specialty
- Clinical Toxicology
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Questions and answers
When was Cedia Dau Opiate Assay cleared by the FDA?
Cedia Dau Opiate Assay (K941195) received a 510(k) decision of Substantially Equivalent on September 7, 1994, 177 days after the submission was received.
What is the product code of K941195?
The FDA product code is DJG – Enzyme Immunoassay, Opiates, a Class II (moderate risk) device regulated under 21 CFR 862.3650.