Selective Culture Medium
FDA 510(k) K850736 · Roseville Medical Laboratoriesu
510(k) numberK850736
Submission
- Device name
- Selective Culture Medium
- Applicant
- Roseville Medical Laboratoriesu
Roseville, CA, US - Received
- February 20, 1985
- Decision date
- March 20, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSI – Culture Media, Selective And Differential
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2360
- Specialty
- Microbiology
Other 510(k)s with product code JSI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K070691 | BBL Chromagar 0157JSI · Traditional | Becton, Dickinson & CO | 11/20/2007SE |
| K974428 | DipstreakJSI · Traditional | Novamed , Ltd. | 07/30/1998SE |
| K891593 | Listeria Selective Enrichment MediumJSI · Traditional | Oxoid U.S.A., Inc. | 06/09/1989SE |
| K890199 | Dentocult Sm-Strip MutansJSI · Traditional | Orion Corp. | 03/02/1989SE |
| K882182 | Salmonella-Shigella (SS) Agar - Product #P3326JSI · Traditional | Lakewood Biochemical Co., Inc. | 06/06/1988SE |
| K881577 | Modified Selective Streptococcus AgarJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881576 | Selenite BrothJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881575 | Selective Streptococcus AgarJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881572 | XL Agar BaseJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881556 | Trichomonas BrothJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
More from Acumedia Manufacturers, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K850738 | Supplement for Culture MediumJSK · Traditional | 03/20/1985SE |
| K850737 | Transport Culture MediumPPM · 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 |
| K850735 | Enriched Culture MediumKZI · Traditional | 03/16/1985SE |
Questions and answers
When was Selective Culture Medium cleared by the FDA?
Selective Culture Medium (K850736) received a 510(k) decision of Substantially Equivalent on March 20, 1985, 28 days after the submission was received.
What is the product code of K850736?
The FDA product code is JSI – Culture Media, Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.