Selenite Broth
FDA 510(k) K881576 · Acumedia Manufacturers, Inc.
510(k) numberK881576
Submission
- Device name
- Selenite Broth
- Applicant
- Acumedia Manufacturers, Inc.
Baltimore, MD, US - Received
- April 11, 1988
- Decision date
- April 18, 1988
- 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 |
| 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 |
| K881555 | Tinsdale Agar BaseJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
More from Acumedia Manufacturers, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K881579 | Amies Transport Medium W/O CharcoalJSN · Traditional | 04/18/1988SE |
| K881578 | StreptoselJSJ · Traditional | 04/18/1988SE |
| K881577 | Modified Selective Streptococcus AgarJSI · Traditional | 04/18/1988SE |
| K881575 | Selective Streptococcus AgarJSI · Traditional | 04/18/1988SE |
| K881574 | W-L Differential MediumJSJ · Traditional | 04/18/1988SE |
| K881573 | Phytone Yeast Extract AgarJSJ · Traditional | 04/18/1988SE |
| K881572 | XL Agar BaseJSI · Traditional | 04/18/1988SE |
| K881571 | Ym BrothJSJ · Traditional | 04/18/1988SE |
| K881570 | Sabouraud Maltose AgarJSJ · Traditional | 04/18/1988SE |
| K881569 | Stuarts Transport MediumJSM · Traditional | 04/18/1988SE |
Questions and answers
When was Selenite Broth cleared by the FDA?
Selenite Broth (K881576) received a 510(k) decision of Substantially Equivalent on April 18, 1988, 7 days after the submission was received.
What is the product code of K881576?
The FDA product code is JSI – Culture Media, Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.