Sabouraud Dextrose Agar
FDA 510(k) K832861 · Troy Biologicals, Inc.
510(k) numberK832861
Submission
- Device name
- Sabouraud Dextrose Agar
- Applicant
- Troy Biologicals, Inc.
Mchenry, IL, US - Received
- August 23, 1983
- Decision date
- September 26, 1983
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K861301 | Bacti Plate (Dermatology) Product No. PS-5000JTZ · Traditional | 04/21/1986SE |
| K832863 | Strep Id QuadJSI · Traditional | 09/26/1983SE |
| K832862 | Transgrow MediumJTY · Traditional | 09/26/1983SE |
| K832860 | SXT Blood AgarJSJ · Traditional | 09/26/1983SE |
| K823311 | Columbia V Agar W/5% Human BloodJSH · Traditional | 12/15/1982SE |
| K823310 | Streptococcus Selective AgarJSI · Traditional | 12/15/1982SE |
| K823307 | Campylobacter Selective AgarJSI · Traditional | 12/15/1982SE |
| K823306 | Hemophilus Quad 10 PlateJSI · Traditional | 12/15/1982SE |
| K823309 | Martin & Lemis Agar W/Vcat InhibitorJTY · Traditional | 12/03/1982SE |
| K823308 | Mycarel Agar Mycobrotic AgarJSJ · Traditional | 12/03/1982SE |
Questions and answers
When was Sabouraud Dextrose Agar cleared by the FDA?
Sabouraud Dextrose Agar (K832861) received a 510(k) decision of Substantially Equivalent on September 26, 1983, 34 days after the submission was received.
What is the product code of K832861?
The FDA product code is JSJ – Culture Media, Selective And Non-Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.