M. Cat. Butyrate Disc
FDA 510(k) K905666 · Carr-Scarborough Microbiologicals, Inc.
510(k) numberK905666
Submission
- Device name
- M. Cat. Butyrate Disc
- Applicant
- Carr-Scarborough Microbiologicals, Inc.
Stone Mountain, GA, US - Received
- December 18, 1990
- Decision date
- February 26, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| 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 |
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|---|---|---|
| K944554 | Brain Heart Infusion AgarJSO · Traditional | 10/04/1994SE |
| K941985 | Mueller Hinton Agar W/OxacillinJTZ · Traditional | 08/24/1994SE |
| K905472 | Lap DiscsJTO · Traditional | 02/27/1991SE |
| K891476 | C. Albicans ScreenJXC · Traditional | 04/12/1989SE |
| K882636 | Aln DiscsJTO · Traditional | 02/16/1989SE |
| K882630 | Pro DiscsJTO · Traditional | 02/16/1989SE |
| K863216 | Neis NzyJTO · Traditional | 09/15/1986SE |
| K860301 | Rapid Glutamic Acid Decarboxylase (GDC) MicrotubeJTO · Traditional | 02/06/1986SE |
| K860302 | Pyr DiscsJTO · Traditional | 02/05/1986SE |
| K822930 | CSM Chromogenic B-Lactamase DiscJTO · Traditional | 11/01/1982SE |
Questions and answers
When was M. Cat. Butyrate Disc cleared by the FDA?
M. Cat. Butyrate Disc (K905666) received a 510(k) decision of Substantially Equivalent on February 26, 1991, 70 days after the submission was received.
What is the product code of K905666?
The FDA product code is JTO – Discs, Strips And Reagents, Microorganism Differentiation, a Class I (low risk) device regulated under 21 CFR 866.2660.