Biotis Decarboxylase Media, Base
FDA 510(k) K862395 · Otisville Biotech, Inc.
510(k) numberK862395
Submission
- Device name
- Biotis Decarboxylase Media, Base
- Applicant
- Otisville Biotech, Inc.
Otisville, NY, US - Received
- June 24, 1986
- Decision date
- July 3, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSH – Culture Media, Non-Selective And Differential
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2320
- Specialty
- Microbiology
Other 510(k)s with product code JSH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K881560 | Urea BrothJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881559 | Urea Agar BaseJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881553 | Russell Double Sugar AgarJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881551 | Phenol Red Broth BaseJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881540 | Flo AgarJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881486 | Dnase Test AgarJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K880121 | Moellers Decarboxylase, BaseJSH · Traditional | Hardy Media | 03/31/1988SE |
| K880117 | Of Medium BaseJSH · Traditional | Hardy Media | 03/30/1988SE |
| K873270 | Actinomycete Differential MediaJSH · Traditional | Central Media | 11/04/1987SE |
| K873263 | Maintenance & Carbohydrate Fermentation MediaJSH · Traditional | Central Media | 10/28/1987SE |
More from Central Media
| 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 |
| 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 |
| K862390 | Biotis Bordet Gengou AgarKZI · Traditional | 07/03/1986SE |
Questions and answers
When was Biotis Decarboxylase Media, Base cleared by the FDA?
Biotis Decarboxylase Media, Base (K862395) received a 510(k) decision of Substantially Equivalent on July 3, 1986, 9 days after the submission was received.
What is the product code of K862395?
The FDA product code is JSH – Culture Media, Non-Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2320.