Iafp Sabouraud Dextrose Agar
FDA 510(k) K872689 · I.A.F. Production, Inc.
510(k) numberK872689
Submission
- Device name
- Iafp Sabouraud Dextrose Agar
- Applicant
- I.A.F. Production, Inc.
Laval, Que. H7n-423, CA - Received
- July 7, 1987
- Decision date
- August 11, 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 |
|---|---|---|
| K872690 | Iafp V. Agar SelectiveJSJ · Traditional | 09/14/1987SE |
| K872692 | Iafp P.E.A. Agar W/5% Sheep BloodJSJ · Traditional | 08/11/1987SE |
| K872691 | Iafp Urea Agar SlantJSF · Traditional | 08/11/1987SE |
| K872688 | Iafp Mueller Hinton Agar W/5% Sheep BloodLKA · Traditional | 08/11/1987SE |
| K872687 | Iafp Mueller Hinton Agar W/Hemo. W/Cva EnrichmentLKA · Traditional | 08/11/1987SE |
| K872686 | Iafp Mueller Hinton AgarLKA · Traditional | 08/11/1987SE |
| K872685 | Iafp Lowenstein Jensen SlantKZI · Traditional | 08/11/1987SE |
| K872684 | Iafp Campylobacter BlaserJSJ · Traditional | 08/11/1987SE |
| K872683 | Iafp Bile Esculin AgarJSI · Traditional | 08/11/1987SE |
| K872682 | Iafp S.S. AgarJSI · Traditional | 08/11/1987SE |
Questions and answers
When was Iafp Sabouraud Dextrose Agar cleared by the FDA?
Iafp Sabouraud Dextrose Agar (K872689) received a 510(k) decision of Substantially Equivalent on August 11, 1987, 35 days after the submission was received.
What is the product code of K872689?
The FDA product code is JSJ – Culture Media, Selective And Non-Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.