B-L Red(Tm) Discs
FDA 510(k) K950346 · Oxis Intl., Inc.
510(k) numberK950346
Submission
- Device name
- B-L Red(Tm) Discs
- Applicant
- Oxis Intl., Inc.
Portland, OR, US - Received
- January 27, 1995
- Decision date
- May 5, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JTO – Discs, Strips And Reagents, Microorganism Differentiation
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
Other 510(k)s with product code JTO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K050352 | In-Vitro Diagnostic Vaginitis Test KitJTO · Traditional | Ameritek Research, LLC | 09/01/2005SE |
| K970832 | Pyr SwabJTO · Traditional | Remel, Inc. | 04/24/1997SE |
| K970834 | Gram SwabJTO · Traditional | Remel, Inc. | 04/17/1997SE |
| K970833 | Indole SwabJTO · Traditional | Remel, Inc. | 04/02/1997SE |
| K970009 | Lyfo(Tm) Differential Disk-BacitracinJTO · Traditional | Microbiologics, Inc. | 02/06/1997SE |
| K962966 | Ids Rapid CB Plus SystemJTO · Traditional | Innovative Diagnostic Systems, Inc. | 10/08/1996SE |
| K961191 | ColiscreenJTO · Traditional | Hardy Diagnostics | 06/17/1996SE |
| K960996 | M. Cat Butyrate DiskJTO · Traditional | Hardy Diagnostics | 04/18/1996SE |
| K955826 | Gibson Id-M. Cat.JTO · Traditional | Gibson Laboratories, Inc. | 02/29/1996SE |
| K954783 | Dryslide CartarrhalisJTO · Traditional | Difco Laboratories, Inc. | 02/06/1996SE |
More from Difco Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K972331 | Innofluor Gentamicin Assay SystemLGQ · Traditional | 08/01/1997SE |
| K972330 | Innofluor Phenobarbital Assay SystemLGQ · Traditional | 07/14/1997SE |
| K970517 | Innofluor Topiramate Control SetLAS · Traditional | 05/12/1997SE |
| 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 |
Questions and answers
When was B-L Red(Tm) Discs cleared by the FDA?
B-L Red(Tm) Discs (K950346) received a 510(k) decision of Substantially Equivalent on May 5, 1995, 98 days after the submission was received.
What is the product code of K950346?
The FDA product code is JTO – Discs, Strips And Reagents, Microorganism Differentiation, a Class I (low risk) device regulated under 21 CFR 866.2660.