Selenite Broth
FDA 510(k) K832614 · Carroll Biological Corp.
510(k) numberK832614
Submission
- Device name
- Selenite Broth
- Applicant
- Carroll Biological Corp.
Mchenry, IL, US - Received
- July 8, 1983
- Decision date
- September 12, 1983
- 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 |
|---|---|---|
| K832243 | Culture Medium for Antimicrobial SusJTZ · Traditional | 09/29/1983SE |
| K832620 | Tryptic Soy Broth MediaJSC · Traditional | 09/12/1983SE |
| K832619 | Thioglycollate MediumJSC · Traditional | 09/12/1983SE |
| K832618 | Blue AgarJSI · Traditional | 09/12/1983SE |
| K832617 | Xylose Lysine DeoxycholateJSI · Traditional | 09/12/1983SE |
| K832616 | Macconkey Agar MediaJSH · Traditional | 09/12/1983SE |
| K832615 | SF BrothJSJ · Traditional | 09/12/1983SE |
| K832613 | Mannitol Salt AgarJSJ · Traditional | 09/12/1983SE |
| K832612 | Chocolate Agar & Thayer Martin AgarJTY · Traditional | 09/12/1983SE |
| K832611 | Tryptic Soy AgarJSG · Traditional | 09/12/1983SE |
Questions and answers
When was Selenite Broth cleared by the FDA?
Selenite Broth (K832614) received a 510(k) decision of Substantially Equivalent on September 12, 1983, 66 days after the submission was received.
What is the product code of K832614?
The FDA product code is JSJ – Culture Media, Selective And Non-Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.