Selective & Non-Differential
FDA 510(k) K841210 · Smith River Biologicals
510(k) numberK841210
Submission
- Device name
- Selective & Non-Differential
- Applicant
- Smith River Biologicals
Mchenry, IL, US - Received
- March 12, 1984
- Decision date
- April 4, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSJ – Culture Media, Selective And Non-Differential
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2360
- Specialty
- Microbiology
Other 510(k)s with product code JSJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K882463 | Potato Dextrose Agar (Pda) - Product #P3421JSJ · Traditional | Lakewood Biochemical Co., Inc. | 06/22/1988SE |
| K881578 | StreptoselJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881574 | W-L Differential MediumJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881573 | Phytone Yeast Extract AgarJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881571 | Ym BrothJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881570 | Sabouraud Maltose AgarJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881565 | Inhibitory Mold AgarJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881561 | Tergitol 7 BrothJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881549 | Mycological Agar W/Low PHJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881547 | Mitis Salivarius AgarJSJ · 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 |
| 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 |
| 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 |
| K841205 | Non Propagating TransportJSM · Traditional | 04/04/1984SE |
Questions and answers
When was Selective & Non-Differential cleared by the FDA?
Selective & Non-Differential (K841210) received a 510(k) decision of Substantially Equivalent on April 4, 1984, 23 days after the submission was received.
What is the product code of K841210?
The FDA product code is JSJ – Culture Media, Selective And Non-Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.