Macconkey Agar
FDA 510(k) K821423 · Interstate Media
510(k) numberK821423
Submission
- Device name
- Macconkey Agar
- Applicant
- Interstate Media
Mchenry, IL, US - Received
- May 12, 1982
- Decision date
- June 1, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSI – Culture Media, Selective And Differential
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2360
- Specialty
- Microbiology
Other 510(k)s with product code JSI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K070691 | BBL Chromagar 0157JSI · Traditional | Becton, Dickinson & CO | 11/20/2007SE |
| K974428 | DipstreakJSI · Traditional | Novamed , Ltd. | 07/30/1998SE |
| K891593 | Listeria Selective Enrichment MediumJSI · Traditional | Oxoid U.S.A., Inc. | 06/09/1989SE |
| K890199 | Dentocult Sm-Strip MutansJSI · Traditional | Orion Corp. | 03/02/1989SE |
| K882182 | Salmonella-Shigella (SS) Agar - Product #P3326JSI · Traditional | Lakewood Biochemical Co., Inc. | 06/06/1988SE |
| K881577 | Modified Selective Streptococcus AgarJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881576 | Selenite BrothJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881575 | Selective Streptococcus AgarJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881572 | XL Agar BaseJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881556 | Trichomonas BrothJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
More from Acumedia Manufacturers, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K821431 | XLD AgarJSI · Traditional | 06/01/1982SE |
| K821430 | Mueller Hinton MediumJTZ · Traditional | 06/01/1982SE |
| K821429 | Mueller Hinton Med. W/5% Sheep BloodJTZ · Traditional | 06/01/1982SE |
| K821428 | Mueller Hinton Chocolate Med. EnrichedJTZ · Traditional | 06/01/1982SE |
| K821427 | Mannitol Salt AgarJSI · Traditional | 06/01/1982SE |
| K821426 | Staphylococcus Medium 1100JSI · Traditional | 06/01/1982SE |
| K821425 | Columbia Blood Agar W/5% Sheep BloodJSH · Traditional | 06/01/1982SE |
| K821424 | Tryptic Soy Agar W/5% Sheep BloodJSH · Traditional | 06/01/1982SE |
| K821422 | SS AgarJSI · Traditional | 06/01/1982SE |
| K821421 | Hektoen Enteric AgarJSI · Traditional | 06/01/1982SE |
Questions and answers
When was Macconkey Agar cleared by the FDA?
Macconkey Agar (K821423) received a 510(k) decision of Substantially Equivalent on June 1, 1982, 20 days after the submission was received.
What is the product code of K821423?
The FDA product code is JSI – Culture Media, Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.