Macconkey Agar
FDA 510(k) K841141 · Anaerobe Systems
510(k) numberK841141
Submission
- Device name
- Macconkey Agar
- Applicant
- Anaerobe Systems
Mchenry, IL, US - Received
- March 16, 1984
- Decision date
- March 26, 1984
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K844383 | Kanamycin 1000 MCG Differential DiskJTO · Traditional | 01/04/1985SE |
| K844382 | Vancomycin 5MCG Differential DiskJTO · Traditional | 01/04/1985SE |
| K844381 | Colistin 10 Mcg. Differential DiskJTO · Traditional | 01/04/1985SE |
| K844380 | Bile Differential DiskJTO · Traditional | 01/04/1985SE |
| K841303 | Campylobacter Thioglycollate MedJSG · Traditional | 04/17/1984SE |
| K841218 | Cycloserine-Cefoxitin Fructose AgarJSI · Traditional | 04/05/1984SE |
| K841142 | Levine Eosin Methylene Blue AgarJSI · Traditional | 04/05/1984SE |
| K841222 | Bacteroides Bile Esculin GarJSI · Traditional | 04/04/1984SE |
| K841221 | Brain Heart Infusion BrothJSC · Traditional | 04/04/1984SE |
| K841220 | Anaerobic Transport MediumJSL · Traditional | 04/04/1984SE |
Questions and answers
When was Macconkey Agar cleared by the FDA?
Macconkey Agar (K841141) received a 510(k) decision of Substantially Equivalent on March 26, 1984, 10 days after the submission was received.
What is the product code of K841141?
The FDA product code is JSI – Culture Media, Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.