Differential Culture Med. Macconkey Agar
FDA 510(k) K841842 · Microline Scientific
510(k) numberK841842
Submission
- Device name
- Differential Culture Med. Macconkey Agar
- Applicant
- Microline Scientific
Mchenry, IL, US - Received
- April 17, 1984
- Decision date
- May 31, 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
| 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 |
|---|---|---|
| K841845 | Selective Culture Med. Columbia CnaJSJ · Traditional | 05/31/1984SE |
| K841844 | Differential Culture Medium-Biggy AgarJSI · Traditional | 05/31/1984SE |
| K841843 | Differential Culture Med. Levine EmbJSH · Traditional | 05/31/1984SE |
| K841586 | Chocolate AgarKZI · Traditional | 05/31/1984SE |
| K841841 | Differential Culture Med. Mannitol SaltJSI · Traditional | 05/25/1984SE |
| K841840 | Selective Culture Med. Phenylethyl AlcoJSJ · Traditional | 05/25/1984SE |
| K841839 | Selective Culture Med. Selective StrepJSJ · Traditional | 05/25/1984SE |
| K841838 | Enriched Culture Med. Tryptic Soy AgarKZI · Traditional | 05/21/1984SE |
| K841837 | Enriched Culture Med. Fluid THIOGLYC0KZI · Traditional | 05/21/1984SE |
| K841836 | Selective Culture Med. TrichomonasJSD · Traditional | 05/14/1984SE |
Questions and answers
When was Differential Culture Med. Macconkey Agar cleared by the FDA?
Differential Culture Med. Macconkey Agar (K841842) received a 510(k) decision of Substantially Equivalent on May 31, 1984, 44 days after the submission was received.
What is the product code of K841842?
The FDA product code is JSI – Culture Media, Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.