Salmonella-Shigella Agar
FDA 510(k) K841746 · The Montana Deaconess Medical Center
510(k) numberK841746
Submission
- Device name
- Salmonella-Shigella Agar
- Applicant
- The Montana Deaconess Medical Center
Mchenry, IL, US - Received
- April 27, 1984
- Decision date
- May 31, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSJ – Culture Media, Selective And Non-Differential
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2360
- Specialty
- Microbiology
Other 510(k)s with product code JSJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K882463 | Potato Dextrose Agar (Pda) - Product #P3421JSJ · Traditional | Lakewood Biochemical Co., Inc. | 06/22/1988SE |
| K881578 | StreptoselJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881574 | W-L Differential MediumJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881573 | Phytone Yeast Extract AgarJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881571 | Ym BrothJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881570 | Sabouraud Maltose AgarJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881565 | Inhibitory Mold AgarJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881561 | Tergitol 7 BrothJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881549 | Mycological Agar W/Low PHJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881547 | Mitis Salivarius AgarJSJ · 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 |
| K841747 | Mannitol Salt 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 |
| 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 Salmonella-Shigella Agar cleared by the FDA?
Salmonella-Shigella Agar (K841746) received a 510(k) decision of Substantially Equivalent on May 31, 1984, 34 days after the submission was received.
What is the product code of K841746?
The FDA product code is JSJ – Culture Media, Selective And Non-Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.