Cedia Dau Barbiturate Assay
FDA 510(k) K945344 · Microgenics Corp.
510(k) numberK945344
Submission
- Device name
- Cedia Dau Barbiturate Assay
- Applicant
- Microgenics Corp.
Concord, CA, US - Received
- November 1, 1994
- Decision date
- December 28, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DIS – Enzyme Immunoassay, Barbiturate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3150
- Specialty
- Clinical Toxicology
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| K092268 | Randox Bariturates AssayDIS · Traditional | Randox Laboratories, Ltd. | 05/25/2011SE |
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| K070098 | Quickscreen Barbiturate 300 Screening Test, Models 9019, 9018; Multi Drug Screening…DIS · Traditional | Phamatech, Inc. | 12/07/2007SE |
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Questions and answers
When was Cedia Dau Barbiturate Assay cleared by the FDA?
Cedia Dau Barbiturate Assay (K945344) received a 510(k) decision of Substantially Equivalent on December 28, 1994, 57 days after the submission was received.
What is the product code of K945344?
The FDA product code is DIS – Enzyme Immunoassay, Barbiturate, a Class II (moderate risk) device regulated under 21 CFR 862.3150.