Macconkey Agar
FDA 510(k) K811477 · Biomedia, Inc.
510(k) numberK811477
Submission
- Device name
- Macconkey Agar
- Applicant
- Biomedia, Inc.
Mchenry, IL, US - Received
- May 26, 1981
- Decision date
- June 18, 1981
- 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 |
|---|---|---|
| K821300 | #2010 Camphylobacter AgarJSI · Traditional | 06/02/1982SE |
| K821302 | #50003 Quad Diagnostic SystemJSH · Traditional | 06/01/1982SE |
| K821301 | #50002 Quad Diagnostic SystemJSI · Traditional | 06/01/1982SE |
| K821108 | Bi Plate-Xld/Hektoen #30012JSI · Traditional | 05/13/1982SE |
| K811479 | Chodolate Agar, EnrichedJTY · Traditional | 06/18/1981SE |
| K811478 | Emb Agar, LevineJSI · Traditional | 06/18/1981SE |
| K811476 | Thayer Martin AgarJTY · Traditional | 06/18/1981SE |
| K811475 | Tryptic Soy Agar W/5% & 10% Sheep BloodJSG · Traditional | 06/18/1981SE |
| K811474 | Tryptic Soy Agar W/5% Sheep Blood & EmbJSI · Traditional | 06/18/1981SE |
| K811473 | Mueller Hinton Agar W/5% Sheep BloodJTZ · Traditional | 06/18/1981SE |
Questions and answers
When was Macconkey Agar cleared by the FDA?
Macconkey Agar (K811477) received a 510(k) decision of Substantially Equivalent on June 18, 1981, 23 days after the submission was received.
What is the product code of K811477?
The FDA product code is JSI – Culture Media, Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.