Apl Sabouraud Dextrose Agar
FDA 510(k) K853231 · Apl Medical Supplies
510(k) numberK853231
Submission
- Device name
- Apl Sabouraud Dextrose Agar
- Applicant
- Apl Medical Supplies
Las Vegas, NV, US - Received
- August 1, 1985
- Decision date
- August 19, 1985
- 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 |
|---|---|---|
| K853619 | Apl Triple Sugar Iron AgarJSH · Traditional | 09/16/1985SE |
| K853618 | Apl Sim MediumJSH · Traditional | 09/16/1985SE |
| K853617 | Apl Simmons Citrate AgarJSI · Traditional | 09/16/1985SE |
| K853610 | Apl Motility Indole Ornithine AgarJSH · Traditional | 09/16/1985SE |
| K853611 | Apl Xylose Lysine Deoxycholate AgarJSI · Traditional | 09/12/1985SE |
| K853609 | Apl Tryptic Soy BrothJSD · Traditional | 09/12/1985SE |
| K853616 | Apl Chlamydospore AgarJSH · Traditional | 09/06/1985SE |
| K853615 | Apl Bile Esculin/Azide AgarJSH · Traditional | 09/06/1985SE |
| K853614 | Apl Fluid Thioglycollate MediumJSH · Traditional | 09/06/1985SE |
| K853613 | Apl GN BrothJSH · Traditional | 09/06/1985SE |
Questions and answers
When was Apl Sabouraud Dextrose Agar cleared by the FDA?
Apl Sabouraud Dextrose Agar (K853231) received a 510(k) decision of Substantially Equivalent on August 19, 1985, 18 days after the submission was received.
What is the product code of K853231?
The FDA product code is JSJ – Culture Media, Selective And Non-Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.