Biotis Bismuth Sulfite Agar
FDA 510(k) K860402 · Otisville Biotech, Inc.
510(k) numberK860402
Submission
- Device name
- Biotis Bismuth Sulfite Agar
- Applicant
- Otisville Biotech, Inc.
Otisville, NY, US - Received
- February 3, 1986
- Decision date
- February 24, 1986
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K862400 | Biotis KV Laked Blood AgarJSJ · Traditional | 07/03/1986SE |
| K862399 | Biotis SXT AgarJSJ · Traditional | 07/03/1986SE |
| K862398 | Biotis Decarboxylase Media, OrnithineJSF · Traditional | 07/03/1986SE |
| K862397 | Biotis Decarboxylase Media, LysineJSF · Traditional | 07/03/1986SE |
| K862396 | Biotis Decarboxylase Media, ArginineJSF · Traditional | 07/03/1986SE |
| K862395 | Biotis Decarboxylase Media, BaseJSH · Traditional | 07/03/1986SE |
| K862394 | Biotis Mitis SalivariusJSI · Traditional | 07/03/1986SE |
| K862393 | Biotis Litmus MilkJSE · Traditional | 07/03/1986SE |
| K862392 | Biotis Motility Test MediumJSF · Traditional | 07/03/1986SE |
| K862391 | Biotis Desoxycholate AgarJSI · Traditional | 07/03/1986SE |
Questions and answers
When was Biotis Bismuth Sulfite Agar cleared by the FDA?
Biotis Bismuth Sulfite Agar (K860402) received a 510(k) decision of Substantially Equivalent on February 24, 1986, 21 days after the submission was received.
What is the product code of K860402?
The FDA product code is JSI – Culture Media, Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.