Biotis (TM) Sabhi (Double Pour)
FDA 510(k) K874179 · Otisville Biopharm, Inc.
510(k) numberK874179
Submission
- Device name
- Biotis (TM) Sabhi (Double Pour)
- Applicant
- Otisville Biopharm, Inc.
Otisville, NY, US - Received
- October 13, 1987
- Decision date
- January 28, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KZI – Culture Media, Enriched
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2330
- Specialty
- Microbiology
Other 510(k)s with product code KZI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K884208 | Listeria Selective Medium (Oxford Formulation)KZI · Traditional | Oxoid U.S.A., Inc. | 10/25/1988SE |
| K881995 | Diamond's Medium ModifiedKZI · Traditional | Remel Co. | 06/02/1988SE |
| K880134 | Middlebrook 7H11 AgarKZI · Traditional | Hardy Media | 03/31/1988SE |
| K880131 | Lowenstein-Jensen, GruftKZI · Traditional | Hardy Media | 03/31/1988SE |
| K880122 | Middlebrook 7H9 BrothKZI · Traditional | Hardy Media | 03/31/1988SE |
| K880138 | Wallenstein Medium SlantKZI · Traditional | Hardy Media | 03/30/1988SE |
| K880109 | Cystine Tryptic Medium BaseKZI · Traditional | Hardy Media | 03/30/1988SE |
| K880127 | Potato Dextrose AgarKZI · Traditional | Hardy Media | 03/07/1988SE |
| K874177 | Biotis (TM) BcyeKZI · Traditional | Otisville Biopharm, Inc. | 12/04/1987SE |
| K873267 | ECG Based MediaKZI · Traditional | Central Media | 11/04/1987SE |
More from Central Media
| 510(k) | Device | Decision |
|---|---|---|
| K874176 | Biotis (TM) Haemophilus DucreyiJSJ · Traditional | 02/05/1988SE |
| K874178 | Biotis (TM) Bcye SelectiveJSJ · Traditional | 12/04/1987SE |
| 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) Sabhi (Double Pour) cleared by the FDA?
Biotis (TM) Sabhi (Double Pour) (K874179) received a 510(k) decision of Substantially Equivalent on January 28, 1988, 107 days after the submission was received.
What is the product code of K874179?
The FDA product code is KZI – Culture Media, Enriched, a Class I (low risk) device regulated under 21 CFR 866.2330.