Randox Bariturates Assay
FDA 510(k) K092268 · Randox Laboratories, Ltd.
510(k) numberK092268
Submission
- Device name
- Randox Bariturates Assay
- Applicant
- Randox Laboratories, Ltd.
Crumlin, GB - Received
- July 28, 2009
- Decision date
- May 25, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| 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 |
| K062165 | Vitros Chemistry Products Barb Reagent; Calibrator Kit 26; FS Calibrator 1; Dat…DIS · Traditional | Ortho-Clinical Diagnostics | 01/05/2007SE |
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Questions and answers
When was Randox Bariturates Assay cleared by the FDA?
Randox Bariturates Assay (K092268) received a 510(k) decision of Substantially Equivalent on May 25, 2011, 666 days after the submission was received.
What is the product code of K092268?
The FDA product code is DIS – Enzyme Immunoassay, Barbiturate, a Class II (moderate risk) device regulated under 21 CFR 862.3150.