Sabouraud Dextrose Agar
FDA 510(k) K832583 · Acuderm, Inc.
510(k) numberK832583
Submission
- Device name
- Sabouraud Dextrose Agar
- Applicant
- Acuderm, Inc.
Mchenry, IL, US - Received
- August 2, 1983
- Decision date
- September 12, 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
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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K933516 | Acu-E PunchLRY · Traditional | 03/24/1994SE |
| K933265 | Acu-Dispo-Ce(Tm)MDM · Traditional | 03/07/1994SE |
| K933137 | Acu-Suture KitLRO · Traditional | 02/22/1994SE |
| K930043 | Acu-EvacFYD · Traditional | 02/09/1994SE |
| K933866 | Acu-Hemostatic RingMDM · Traditional | 12/01/1993SE |
| K915000 | Acu-GuardGEX · Traditional | 01/27/1992SE |
| K891334 | Acu-CuretteFZS · Traditional | 04/11/1989SE |
| K874024 | Acu-Micro-NeedleFMI · Traditional | 11/23/1987SE |
| K854877 | Acu-Syringe W/Wo NeedlesFMF · Traditional | 02/19/1986SE |
| K832582 | Mycosel AgarJSJ · Traditional | 09/12/1983SE |
Questions and answers
When was Sabouraud Dextrose Agar cleared by the FDA?
Sabouraud Dextrose Agar (K832583) received a 510(k) decision of Substantially Equivalent on September 12, 1983, 41 days after the submission was received.
What is the product code of K832583?
The FDA product code is JSJ – Culture Media, Selective And Non-Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.