Lyfo(Tm) Differential Disk-Bacitracin
FDA 510(k) K970009 · Microbiologics, Inc.
510(k) numberK970009
Submission
- Device name
- Lyfo(Tm) Differential Disk-Bacitracin
- Applicant
- Microbiologics, Inc.
St. Cloud, MN, US - Received
- January 2, 1997
- Decision date
- February 6, 1997
- 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
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| 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 |
| 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 |
| K954812 | Lyfo(Tm) Differiental Disk-PyrJTO · Traditional | Microbiologics, Inc. | 12/20/1995SE |
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| K954812 | Lyfo(Tm) Differiental Disk-PyrJTO · Traditional | 12/20/1995SE |
| K951889 | Lyfo(Tm) Differential DiskJTO · Traditional | 08/24/1995SE |
Questions and answers
When was Lyfo(Tm) Differential Disk-Bacitracin cleared by the FDA?
Lyfo(Tm) Differential Disk-Bacitracin (K970009) received a 510(k) decision of Substantially Equivalent on February 6, 1997, 35 days after the submission was received.
What is the product code of K970009?
The FDA product code is JTO – Discs, Strips And Reagents, Microorganism Differentiation, a Class I (low risk) device regulated under 21 CFR 866.2660.