Kanamycin 1000 MCG Differential Disk
FDA 510(k) K844383 · Anaerobe Systems
510(k) numberK844383
Submission
- Device name
- Kanamycin 1000 MCG Differential Disk
- Applicant
- Anaerobe Systems
Walker, MI, US - Received
- November 13, 1984
- Decision date
- January 4, 1985
- 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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| K962966 | Ids Rapid CB Plus SystemJTO · Traditional | Innovative Diagnostic Systems, Inc. | 10/08/1996SE |
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| 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 |
|---|---|---|
| K844382 | Vancomycin 5MCG Differential DiskJTO · Traditional | 01/04/1985SE |
| K844381 | Colistin 10 Mcg. Differential DiskJTO · Traditional | 01/04/1985SE |
| K844380 | Bile Differential DiskJTO · Traditional | 01/04/1985SE |
| K841303 | Campylobacter Thioglycollate MedJSG · Traditional | 04/17/1984SE |
| K841218 | Cycloserine-Cefoxitin Fructose AgarJSI · Traditional | 04/05/1984SE |
| K841142 | Levine Eosin Methylene Blue AgarJSI · Traditional | 04/05/1984SE |
| K841222 | Bacteroides Bile Esculin GarJSI · Traditional | 04/04/1984SE |
| K841221 | Brain Heart Infusion BrothJSC · Traditional | 04/04/1984SE |
| K841220 | Anaerobic Transport MediumJSL · Traditional | 04/04/1984SE |
| K841219 | Shopped Meat CarbohydrateJSC · Traditional | 04/04/1984SE |
Questions and answers
When was Kanamycin 1000 MCG Differential Disk cleared by the FDA?
Kanamycin 1000 MCG Differential Disk (K844383) received a 510(k) decision of Substantially Equivalent on January 4, 1985, 52 days after the submission was received.
What is the product code of K844383?
The FDA product code is JTO – Discs, Strips And Reagents, Microorganism Differentiation, a Class I (low risk) device regulated under 21 CFR 866.2660.