Selective Broth
FDA 510(k) K841211 · Smith River Biologicals
510(k) numberK841211
Submission
- Device name
- Selective Broth
- Applicant
- Smith River Biologicals
Mchenry, IL, US - Received
- March 12, 1984
- Decision date
- April 5, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSD – Culture Media, Selective Broth
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2360
- Specialty
- Microbiology
Other 510(k)s with product code JSD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K883075 | Fastidious Inoculum BrothJSD · Traditional | Baxter Healthcare Corp | 08/15/1988SE |
| K880107 | Campy BrothJSD · Traditional | Hardy Media | 03/30/1988SE |
| K873324 | Sabouraud Dextrose (SD) Broth Tube, #T3331JSD · Traditional | Lakewood Biochemical Co., Inc. | 10/02/1987SE |
| K873218 | Brain Heart Infusion Broth W/6.5% NAC1 - #T3802JSD · Traditional | Lakewood Biochemical Co., Inc. | 09/23/1987SE |
| K871640 | Alkaline Peptone WaterJSD · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 05/13/1987SE |
| K871447 | Todd Hewitt W/Cna (Lim Broth)JSD · Traditional | Remel Co. | 05/13/1987SE |
| K870594 | T9802 TSB W/6.5% NaclJSD · Traditional | Lakewood Biochemical Co., Inc. | 03/30/1987SE |
| K853609 | Apl Tryptic Soy BrothJSD · Traditional | Apl Medical Supplies | 09/12/1985SE |
| K844547 | Tryptic Soy Broth W/6.5%SODIUM ChlorideJSD · Traditional | bioMerieux, Inc. | 01/16/1985SE |
| K841836 | Selective Culture Med. TrichomonasJSD · Traditional | Microline Scientific | 05/14/1984SE |
More from Microline Scientific
| 510(k) | Device | Decision |
|---|---|---|
| K923892 | Smith River Microbiological Culture MediaJSO · Traditional | 06/21/1993SE |
| K841209 | Selective and DifferentialJSI · Traditional | 04/17/1984SE |
| 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 |
| 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 Broth cleared by the FDA?
Selective Broth (K841211) received a 510(k) decision of Substantially Equivalent on April 5, 1984, 24 days after the submission was received.
What is the product code of K841211?
The FDA product code is JSD – Culture Media, Selective Broth, a Class I (low risk) device regulated under 21 CFR 866.2360.