Biotis Decarboxylase Media, Lysine
FDA 510(k) K862397 · Otisville Biotech, Inc.
510(k) numberK862397
Submission
- Device name
- Biotis Decarboxylase Media, Lysine
- 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
- JSF – Culture Media, Single Biochemical Test
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2320
- Specialty
- Microbiology
Other 510(k)s with product code JSF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K880946 | Nutrient Gelatin - Product Number T2860JSF · Traditional | Lakewood Biochemical Co., Inc. | 04/01/1988SE |
| K880126 | Lauryl Tryptose BrothJSF · Traditional | Hardy Media | 03/31/1988SE |
| K880120 | Moellers Decarboxylase, LysineJSF · Traditional | Hardy Media | 03/31/1988SE |
| K880119 | Moellers Decarboxylase, OnithineJSF · Traditional | Hardy Media | 03/31/1988SE |
| K880139 | Onpg Test ReagentJSF · Traditional | Hardy Media | 03/30/1988SE |
| K880135 | Nitrate BrothJSF · Traditional | Hardy Media | 03/30/1988SE |
| K880129 | Brilliant Green Bile BrothJSF · Traditional | Hardy Media | 03/30/1988SE |
| K880118 | Moelloers Decarboxylase, ArginineJSF · Traditional | Hardy Media | 03/30/1988SE |
| K880113 | Cystine Tryptic Medium W/LactoseJSF · Traditional | Hardy Media | 03/30/1988SE |
| K880112 | Cystine Tryptic Medium W/ MaltoseJSF · Traditional | Hardy Media | 03/30/1988SE |
More from Hardy 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 |
| 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 |
| K862390 | Biotis Bordet Gengou AgarKZI · Traditional | 07/03/1986SE |
Questions and answers
When was Biotis Decarboxylase Media, Lysine cleared by the FDA?
Biotis Decarboxylase Media, Lysine (K862397) 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 K862397?
The FDA product code is JSF – Culture Media, Single Biochemical Test, a Class I (low risk) device regulated under 21 CFR 866.2320.