Biotis (TM) Bcye Selective
FDA 510(k) K874178 · Otisville Biopharm, Inc.
510(k) numberK874178
Submission
- Device name
- Biotis (TM) Bcye Selective
- Applicant
- Otisville Biopharm, Inc.
Otisville, NY, US - Received
- October 13, 1987
- Decision date
- December 4, 1987
- 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
Other 510(k)s with product code JSJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K882463 | Potato Dextrose Agar (Pda) - Product #P3421JSJ · Traditional | Lakewood Biochemical Co., Inc. | 06/22/1988SE |
| K881578 | StreptoselJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881574 | W-L Differential MediumJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881573 | Phytone Yeast Extract AgarJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881571 | Ym BrothJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| 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 |
| K881549 | Mycological Agar W/Low PHJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881547 | Mitis Salivarius AgarJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
More from Acumedia Manufacturers, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K874176 | Biotis (TM) Haemophilus DucreyiJSJ · Traditional | 02/05/1988SE |
| K874179 | Biotis (TM) Sabhi (Double Pour)KZI · Traditional | 01/28/1988SE |
| K874177 | Biotis (TM) BcyeKZI · Traditional | 12/04/1987SE |
| K874175 | Biotis (TM) Mueller Hinton W/4% Salt, 6MCG/ML OxacJSF · Traditional | 12/04/1987SE |
| K874174 | Biotis (TM) Starch Hydrolysis with BCPJSF · Traditional | 12/04/1987SE |
| K874173 | Biotis (TM) Bhi with HRBC, Chlora/Gentam/CyclohexiJSJ · Traditional | 10/28/1987SE |
| K874172 | Biotis (TM) Inhibitory Mold Agar (Double Pour)JSJ · Traditional | 10/28/1987SE |
Questions and answers
When was Biotis (TM) Bcye Selective cleared by the FDA?
Biotis (TM) Bcye Selective (K874178) received a 510(k) decision of Substantially Equivalent on December 4, 1987, 52 days after the submission was received.
What is the product code of K874178?
The FDA product code is JSJ – Culture Media, Selective And Non-Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.