Biotis Sabhi with Chloramphenical and Gentamycin
FDA 510(k) K860390 · Otisville Biotech, Inc.
510(k) numberK860390
Submission
- Device name
- Biotis Sabhi with Chloramphenical and Gentamycin
- 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
- JSJ – Culture Media, Selective And Non-Differential
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2360
- Specialty
- Microbiology
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| K881570 | Sabouraud Maltose AgarJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881565 | Inhibitory Mold AgarJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881561 | Tergitol 7 BrothJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
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| K881547 | Mitis Salivarius AgarJSJ · 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 Sabhi with Chloramphenical and Gentamycin cleared by the FDA?
Biotis Sabhi with Chloramphenical and Gentamycin (K860390) 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 K860390?
The FDA product code is JSJ – Culture Media, Selective And Non-Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.