Mannitol Salt Agar
FDA 510(k) K841747 · The Montana Deaconess Medical Center
510(k) numberK841747
Submission
- Device name
- Mannitol Salt Agar
- Applicant
- The Montana Deaconess Medical Center
Mchenry, IL, US - Received
- April 27, 1984
- Decision date
- June 7, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSI – Culture Media, Selective And Differential
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2360
- Specialty
- Microbiology
Other 510(k)s with product code JSI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K070691 | BBL Chromagar 0157JSI · Traditional | Becton, Dickinson & CO | 11/20/2007SE |
| K974428 | DipstreakJSI · Traditional | Novamed , Ltd. | 07/30/1998SE |
| K891593 | Listeria Selective Enrichment MediumJSI · Traditional | Oxoid U.S.A., Inc. | 06/09/1989SE |
| K890199 | Dentocult Sm-Strip MutansJSI · Traditional | Orion Corp. | 03/02/1989SE |
| K882182 | Salmonella-Shigella (SS) Agar - Product #P3326JSI · Traditional | Lakewood Biochemical Co., Inc. | 06/06/1988SE |
| K881577 | Modified Selective Streptococcus AgarJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881576 | Selenite BrothJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881575 | Selective Streptococcus AgarJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881572 | XL Agar BaseJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881556 | Trichomonas BrothJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
More from Acumedia Manufacturers, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K841753 | Macconkey AgarJSI · Traditional | 06/07/1984SE |
| K841752 | Xylose-Lysine Desoxycholate AgarJSI · Traditional | 06/07/1984SE |
| K841751 | Levine Eosin Methylene Blue AgarJSI · Traditional | 05/31/1984SE |
| K841750 | Martin-Lewis AgarJTY · Traditional | 05/31/1984SE |
| K841749 | Chocolate AgarKZI · Traditional | 05/31/1984SE |
| K841748 | Sheep Blood AgarKZI · Traditional | 05/31/1984SE |
| K841746 | Salmonella-Shigella AgarJSJ · Traditional | 05/31/1984SE |
| K841755 | Mueller-Hinton AgarJTZ · Traditional | 05/14/1984SE |
| K841745 | Hektoen Enteric AgarJSI · Traditional | 05/11/1984SE |
| K841754 | Columbia Cna AgarJSJ · Traditional | 05/07/1984SE |
Questions and answers
When was Mannitol Salt Agar cleared by the FDA?
Mannitol Salt Agar (K841747) received a 510(k) decision of Substantially Equivalent on June 7, 1984, 41 days after the submission was received.
What is the product code of K841747?
The FDA product code is JSI – Culture Media, Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.