Macconkey Agar Media
FDA 510(k) K832616 · Carroll Biological Corp.
510(k) numberK832616
Submission
- Device name
- Macconkey Agar Media
- 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
- JSH – Culture Media, Non-Selective And Differential
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2320
- Specialty
- Microbiology
Other 510(k)s with product code JSH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K881560 | Urea BrothJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881559 | Urea Agar BaseJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881553 | Russell Double Sugar AgarJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881551 | Phenol Red Broth BaseJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881540 | Flo AgarJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881486 | Dnase Test AgarJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K880121 | Moellers Decarboxylase, BaseJSH · Traditional | Hardy Media | 03/31/1988SE |
| K880117 | Of Medium BaseJSH · Traditional | Hardy Media | 03/30/1988SE |
| K873270 | Actinomycete Differential MediaJSH · Traditional | Central Media | 11/04/1987SE |
| K873263 | Maintenance & Carbohydrate Fermentation MediaJSH · Traditional | Central Media | 10/28/1987SE |
More from Central Media
| 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 |
| K832615 | SF BrothJSJ · Traditional | 09/12/1983SE |
| K832614 | Selenite 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 Macconkey Agar Media cleared by the FDA?
Macconkey Agar Media (K832616) 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 K832616?
The FDA product code is JSH – Culture Media, Non-Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2320.