Innofluor Topiramate Control Set
FDA 510(k) K970517 · Oxis Intl., Inc.
510(k) numberK970517
Submission
- Device name
- Innofluor Topiramate Control Set
- Applicant
- Oxis Intl., Inc.
Portland, OR, US - Received
- February 11, 1997
- Decision date
- May 12, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LAS – Drug Specific Control Materials
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3280
- Specialty
- Clinical Toxicology
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More from Roche Diagnostic Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K972331 | Innofluor Gentamicin Assay SystemLGQ · Traditional | 08/01/1997SE |
| K972330 | Innofluor Phenobarbital Assay SystemLGQ · Traditional | 07/14/1997SE |
| K970510 | Innoflour Topiramate Reagent SetMSL · Traditional | 05/12/1997SE |
| K970509 | Innoflour Calibrator Reagent SetDLJ · Traditional | 05/12/1997SE |
| K955568 | Innofluor Quinidine Assay SystemLBZ · Traditional | 04/04/1996SE |
| K955570 | Innofluor Amikacin Assay SystemKLQ · Traditional | 02/09/1996SE |
| K955569 | Innofluor Gentamicin Assay SystemLCQ · Traditional | 02/09/1996SE |
| K955567 | Innofluor Theophylline Assay SystemLGS · Traditional | 01/24/1996SE |
| K955562 | Innofluor Phenytoin Assay SystemLGR · Traditional | 01/24/1996SE |
| K950346 | B-L Red(Tm) DiscsJTO · Traditional | 05/05/1995SE |
Questions and answers
When was Innofluor Topiramate Control Set cleared by the FDA?
Innofluor Topiramate Control Set (K970517) received a 510(k) decision of Substantially Equivalent on May 12, 1997, 90 days after the submission was received.
What is the product code of K970517?
The FDA product code is LAS – Drug Specific Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.