Biotis Sim Medium
FDA 510(k) K860412 · Otisville Biotech, Inc.
510(k) numberK860412
Submission
- Device name
- Biotis Sim Medium
- 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
- JSE – Culture Media, Multiple Biochemical Test
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2320
- Specialty
- Microbiology
Other 510(k)s with product code JSE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K962265 | MLX Microtiter Plate LuminometerJSE · Traditional | Dynatech Laboratories, Inc. | 07/25/1996SE |
| K883996 | X-Act Ldc/IndJSE · Traditional | Pro-Lab, Inc. | 10/12/1988SE |
| K883995 | X-Act Urea/TdaJSE · Traditional | Pro-Lab, Inc. | 10/12/1988SE |
| K880133 | Mil MediumJSE · Traditional | Hardy Media | 03/31/1988SE |
| K880116 | MRVP BrothJSE · Traditional | Hardy Media | 03/31/1988SE |
| K874537 | Kligler Iron Agar and Triple Sugar Iron AgarJSE · Traditional | Lakewood Biochemical Co., Inc. | 11/20/1987SE |
| K871096 | Cystine Tryptic Agar W/O CarbohydratesJSE · Traditional | bioMerieux, Inc. | 04/03/1987SE |
| K864674 | Microdilution Identification PanelsJSE · Traditional | American Micro Scan | 01/05/1987SE |
| K862393 | Biotis Litmus MilkJSE · Traditional | Otisville Biotech, Inc. | 07/03/1986SE |
| K860415 | Biotis Simmon Citrate AgarJSE · Traditional | Otisville Biotech, Inc. | 02/24/1986SE |
More from Otisville Biotech, 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 Sim Medium cleared by the FDA?
Biotis Sim Medium (K860412) 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 K860412?
The FDA product code is JSE – Culture Media, Multiple Biochemical Test, a Class I (low risk) device regulated under 21 CFR 866.2320.