Selective and Differential
FDA 510(k) K841209 · Smith River Biologicals
510(k) numberK841209
Submission
- Device name
- Selective and Differential
- Applicant
- Smith River Biologicals
Mchenry, IL, US - Received
- March 12, 1984
- Decision date
- April 17, 1984
- 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 |
|---|---|---|
| K923892 | Smith River Microbiological Culture MediaJSO · Traditional | 06/21/1993SE |
| K841207 | Non-Selective & Non-DifferentialJSI · Traditional | 04/17/1984SE |
| K841206 | Non-Selective & DifferentialJSH · Traditional | 04/17/1984SE |
| K841204 | Multiple Biochemical TestJSE · Traditional | 04/17/1984SE |
| K841211 | Selective BrothJSD · Traditional | 04/05/1984SE |
| K841208 | Propagating TransportJSN · Traditional | 04/05/1984SE |
| K841213 | Antimicrobial Suscept-Culture MediaJTZ · Traditional | 04/04/1984SE |
| K841212 | Single Biochemical TestJSF · Traditional | 04/04/1984SE |
| K841210 | Selective & Non-DifferentialJSJ · Traditional | 04/04/1984SE |
| K841205 | Non Propagating TransportJSM · Traditional | 04/04/1984SE |
Questions and answers
When was Selective and Differential cleared by the FDA?
Selective and Differential (K841209) received a 510(k) decision of Substantially Equivalent on April 17, 1984, 36 days after the submission was received.
What is the product code of K841209?
The FDA product code is JSI – Culture Media, Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.