Selenite F Broth
FDA 510(k) K850716 · Rapid City Regional Hospital, Inc.
510(k) numberK850716
Submission
- Device name
- Selenite F Broth
- Applicant
- Rapid City Regional Hospital, Inc.
Rapid City, SD, US - Received
- February 22, 1985
- Decision date
- March 22, 1985
- 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 |
|---|---|---|
| K850724 | Culture Media Nonselective & NondifferentialKZI · Traditional | 03/25/1985SE |
| K850723 | Sabouraud's Dextrose Agar, Bordet Gengou Agar, MycJSI · Traditional | 03/22/1985SE |
| K850722 | Martin Lewis AgarJTY · Traditional | 03/22/1985SE |
| K850721 | Kliger's Iron Agar, Sim Media, MRVP Medium, Bile EJSH · Traditional | 03/22/1985SE |
| K850720 | Eosin Methylene Blue Agar, SS Agar, XLD Agar 6.5%JSI · Traditional | 03/22/1985SE |
| K850719 | Dnase Test Media, Christensen's Urea AgarJSH · Traditional | 03/22/1985SE |
| K850717 | Amies Transport MediaJSM · Traditional | 03/22/1985SE |
| K850715 | Mueller Hinton AgarJTZ · Traditional | 03/22/1985SE |
| K850718 | Corn Meal AgarJSH · Traditional | 03/20/1985SE |
Questions and answers
When was Selenite F Broth cleared by the FDA?
Selenite F Broth (K850716) received a 510(k) decision of Substantially Equivalent on March 22, 1985, 28 days after the submission was received.
What is the product code of K850716?
The FDA product code is JSJ – Culture Media, Selective And Non-Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.