Bile Esculin Agar
FDA 510(k) K851578 · Preferred Micro-Media
510(k) numberK851578
Submission
- Device name
- Bile Esculin Agar
- Applicant
- Preferred Micro-Media
Toledo, OH, US - Received
- April 16, 1985
- Decision date
- May 8, 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 |
|---|---|---|
| K851594 | SF BrothJSI · Traditional | 05/14/1985SE |
| K851597 | Triple Sugar Iron AgarJSH · Traditional | 05/13/1985SE |
| K851596 | Sim MediumJSH · Traditional | 05/13/1985SE |
| K851595 | Simmons Citrate AgarJSH · Traditional | 05/13/1985SE |
| K851593 | Selective Streptococcus AgarJSJ · Traditional | 05/13/1985SE |
| K851592 | Sabouraud Dextrose AgarJSJ · Traditional | 05/13/1985SE |
| K851591 | Phenylethyl Alcohol Agar W/5%SHEEP BloodJSJ · Traditional | 05/13/1985SE |
| K851598 | Thioglycollate Without IndicatorJSG · Traditional | 05/10/1985SE |
| K851576 | Biggy Agar Nickersons MediumJSH · Traditional | 05/09/1985SE |
| K851603 | Xylose Lysine Desoxycholate AgarJSI · Traditional | 05/08/1985SE |
Questions and answers
When was Bile Esculin Agar cleared by the FDA?
Bile Esculin Agar (K851578) received a 510(k) decision of Substantially Equivalent on May 8, 1985, 22 days after the submission was received.
What is the product code of K851578?
The FDA product code is JSI – Culture Media, Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.