Lyfo(Tm) Differential Disk-Sps
FDA 510(k) K945880 · Microbiologics, Inc.
510(k) numberK945880
Submission
- Device name
- Lyfo(Tm) Differential Disk-Sps
- Applicant
- Microbiologics, Inc.
St. Cloud, MN, US - Received
- December 1, 1994
- Decision date
- April 24, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K190086 | Cepheid Xpert Respiratory Control PanelPMN · Traditional | 10/07/2019SE |
| K191168 | Cepheid Xpert SA Nasal Complete Control PanelPMN · Traditional | 06/25/2019SE |
| K191172 | Cepheid Xpert MRSA NxG Control PanelPMN · Traditional | 06/20/2019SE |
| K190223 | Cepheid Xpert CT/NG Control PanelPMN · Traditional | 05/08/2019SE |
| K190463 | Cepheid Xpert C. difficile/Epi Control PanelPMN · Traditional | 04/19/2019SE |
| K182472 | Cepheid Xpert GBS LB Control PanelPMN · Traditional | 11/08/2018SE |
| K181683 | BD MAX CT/GC/TV 20-Day QC PanelPMN · Traditional | 08/28/2018SE |
| K181711 | BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC PanelPMN · Traditional | 08/15/2018SE |
| K970009 | Lyfo(Tm) Differential Disk-BacitracinJTO · Traditional | 02/06/1997SE |
| K954812 | Lyfo(Tm) Differiental Disk-PyrJTO · Traditional | 12/20/1995SE |
Questions and answers
When was Lyfo(Tm) Differential Disk-Sps cleared by the FDA?
Lyfo(Tm) Differential Disk-Sps (K945880) received a 510(k) decision of Substantially Equivalent on April 24, 1995, 144 days after the submission was received.
What is the product code of K945880?
The FDA product code is JTO – Discs, Strips And Reagents, Microorganism Differentiation, a Class I (low risk) device regulated under 21 CFR 866.2660.