Sabouraud's Dextrose Agar, Bordet Gengou Agar, Myc
FDA 510(k) K850723 · Rapid City Regional Hospital, Inc.
510(k) numberK850723
Submission
- Device name
- Sabouraud's Dextrose Agar, Bordet Gengou Agar, Myc
- Applicant
- Rapid City Regional Hospital, Inc.
Rapid City, SD, US - Received
- February 22, 1985
- Decision date
- March 22, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSI – Culture Media, Selective And Differential
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2360
- Specialty
- Microbiology
Other 510(k)s with product code JSI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K070691 | BBL Chromagar 0157JSI · Traditional | Becton, Dickinson & CO | 11/20/2007SE |
| K974428 | DipstreakJSI · Traditional | Novamed , Ltd. | 07/30/1998SE |
| K891593 | Listeria Selective Enrichment MediumJSI · Traditional | Oxoid U.S.A., Inc. | 06/09/1989SE |
| K890199 | Dentocult Sm-Strip MutansJSI · Traditional | Orion Corp. | 03/02/1989SE |
| K882182 | Salmonella-Shigella (SS) Agar - Product #P3326JSI · Traditional | Lakewood Biochemical Co., Inc. | 06/06/1988SE |
| K881577 | Modified Selective Streptococcus AgarJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881576 | Selenite BrothJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881575 | Selective Streptococcus AgarJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881572 | XL Agar BaseJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881556 | Trichomonas BrothJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
More from Acumedia Manufacturers, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K850724 | Culture Media Nonselective & NondifferentialKZI · Traditional | 03/25/1985SE |
| K850722 | Martin Lewis AgarJTY · Traditional | 03/22/1985SE |
| K850721 | Kliger's Iron Agar, Sim Media, MRVP Medium, Bile EJSH · Traditional | 03/22/1985SE |
| K850720 | Eosin Methylene Blue Agar, SS Agar, XLD Agar 6.5%JSI · Traditional | 03/22/1985SE |
| K850719 | Dnase Test Media, Christensen's Urea AgarJSH · Traditional | 03/22/1985SE |
| K850717 | Amies Transport MediaJSM · Traditional | 03/22/1985SE |
| K850716 | Selenite F BrothJSJ · Traditional | 03/22/1985SE |
| K850715 | Mueller Hinton AgarJTZ · Traditional | 03/22/1985SE |
| K850718 | Corn Meal AgarJSH · Traditional | 03/20/1985SE |
Questions and answers
When was Sabouraud's Dextrose Agar, Bordet Gengou Agar, Myc cleared by the FDA?
Sabouraud's Dextrose Agar, Bordet Gengou Agar, Myc (K850723) received a 510(k) decision of Substantially Equivalent on March 22, 1985, 28 days after the submission was received.
What is the product code of K850723?
The FDA product code is JSI – Culture Media, Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.