Enriched Culture Medium
FDA 510(k) K850735 · Roseville Medical Laboratoriesu
510(k) numberK850735
Submission
- Device name
- Enriched Culture Medium
- Applicant
- Roseville Medical Laboratoriesu
Roseville, CA, US - Received
- February 20, 1985
- Decision date
- March 16, 1985
- 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 |
| K874179 | Biotis (TM) Sabhi (Double Pour)KZI · Traditional | Otisville Biopharm, Inc. | 01/28/1988SE |
| K874177 | Biotis (TM) BcyeKZI · Traditional | Otisville Biopharm, Inc. | 12/04/1987SE |
More from Otisville Biopharm, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K850738 | Supplement for Culture MediumJSK · Traditional | 03/20/1985SE |
| K850737 | Transport Culture MediumPPM · Traditional | 03/20/1985SE |
| K850736 | Selective Culture MediumJSI · Traditional | 03/20/1985SE |
| K850734 | Differential Culture MediumJSE · Traditional | 03/20/1985SE |
| K850733 | Multipurpose Culture MediumJSG · Traditional | 03/20/1985SE |
| K850732 | Culture Medium for Pathogenic Neisseria Ssp.MiJTY · Traditional | 03/20/1985SE |
| K850731 | Culture Medium for Antimicrobial Suscep. TestingJTZ · Traditional | 03/20/1985SE |
Questions and answers
When was Enriched Culture Medium cleared by the FDA?
Enriched Culture Medium (K850735) received a 510(k) decision of Substantially Equivalent on March 16, 1985, 24 days after the submission was received.
What is the product code of K850735?
The FDA product code is KZI – Culture Media, Enriched, a Class I (low risk) device regulated under 21 CFR 866.2330.