Sabouraud Dextrose Agar
FDA 510(k) K864250 · Mds Laboratories, Inc.
510(k) numberK864250
Submission
- Device name
- Sabouraud Dextrose Agar
- Applicant
- Mds Laboratories, Inc.
L5j 2m4, CA - Received
- October 28, 1986
- Decision date
- March 31, 1987
- 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 |
|---|---|---|
| K864256 | Tryptone Water (1%)JSF · Traditional | 03/31/1987SE |
| K864255 | Trypticase Soy BrothJSG · Traditional | 03/31/1987SE |
| K864254 | Thioglycollate BrothJSG · Traditional | 03/31/1987SE |
| K864253 | Thayer Martin AgarJTY · Traditional | 03/31/1987SE |
| K864252 | Thayer-Martin JembecJTY · Traditional | 03/31/1987SE |
| K864251 | Selenite F. BrothJSJ · Traditional | 03/31/1987SE |
| K864249 | Normal Saline SterileLIB · Traditional | 03/31/1987SE |
| K864248 | Mueller Hinton Agar - SupplementedJTZ · Traditional | 03/31/1987SE |
| K864247 | Mueller Hinton Agar with 5% Sheep BloodJTZ · Traditional | 03/31/1987SE |
| K864246 | Mueller Hinton Agar LargeJTZ · Traditional | 03/31/1987SE |
Questions and answers
When was Sabouraud Dextrose Agar cleared by the FDA?
Sabouraud Dextrose Agar (K864250) received a 510(k) decision of Substantially Equivalent on March 31, 1987, 154 days after the submission was received.
What is the product code of K864250?
The FDA product code is JSJ – Culture Media, Selective And Non-Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.