Txit D.A.U. Barbiturate Assay (Modification)
FDA 510(k) K920314 · Syntex Corp.
510(k) numberK920314
Submission
- Device name
- Txit D.A.U. Barbiturate Assay (Modification)
- Applicant
- Syntex Corp.
San Jose, CA, US - Received
- January 23, 1992
- Decision date
- April 17, 1992
- 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 |
| K110515 | Ucp Drug Screening Test CupsDIS · Special | Ucp Biosciences, Inc. | 04/20/2011SE |
| K070098 | Quickscreen Barbiturate 300 Screening Test, Models 9019, 9018; Multi Drug Screening…DIS · Traditional | Phamatech, Inc. | 12/07/2007SE |
| K070009 | At Home Drug Test Models, 9308T and 9308XDIS · Traditional | Phamatech, Inc. | 12/07/2007SE |
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Questions and answers
When was Txit D.A.U. Barbiturate Assay (Modification) cleared by the FDA?
Txit D.A.U. Barbiturate Assay (Modification) (K920314) received a 510(k) decision of Substantially Equivalent on April 17, 1992, 85 days after the submission was received.
What is the product code of K920314?
The FDA product code is DIS – Enzyme Immunoassay, Barbiturate, a Class II (moderate risk) device regulated under 21 CFR 862.3150.