Martin-Lewis Agar
FDA 510(k) K841750 · The Montana Deaconess Medical Center
510(k) numberK841750
Submission
- Device name
- Martin-Lewis Agar
- Applicant
- The Montana Deaconess Medical Center
Mchenry, IL, US - Received
- April 27, 1984
- Decision date
- May 31, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JTY – Culture Media, For Isolation Of Pathogenic Neisseria
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.2410
- Specialty
- Microbiology
Other 510(k)s with product code JTY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K210511 | InTray GCJTY · Traditional | Biomed Diagnostics Incorporated | 10/20/2021SE |
| K993033 | Intray GCJTY · Traditional | Biomed Diagnostics, Inc. | 12/16/1999SE |
| K954986 | GC Base W/ 1% GchiJTY · Traditional | Remel, L.P. | 02/16/1996SE |
| K950196 | Culture Media, for Isolation of Pathogenic NeisseriaJTY · Traditional | Bioclinical Systems, Inc. | 06/30/1995SE |
| K933122 | Microbiological Culture Media,Martin Lewis AgarJTY · Traditional | Bioclinical Systems, Inc. | 02/09/1994SE |
| K933121 | Microbiological Culture Media,Chocolate AgarJTY · Traditional | Bioclinical Systems, Inc. | 02/03/1994SE |
| K934331 | Thayer Martin, Modified Pill PocketJTY · Traditional | Hardy Diagnostics | 12/21/1993SE |
| K934330 | TransgrowJTY · Traditional | Hardy Diagnostics | 12/17/1993SE |
| K931864 | Martin Lewis with LinocmycinJTY · Traditional | Hardy Diagnostics | 12/15/1993SE |
| K881552 | Proteose No. 3 AgarJTY · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
More from Acumedia Manufacturers, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K841753 | Macconkey AgarJSI · Traditional | 06/07/1984SE |
| K841752 | Xylose-Lysine Desoxycholate AgarJSI · Traditional | 06/07/1984SE |
| K841747 | Mannitol Salt AgarJSI · Traditional | 06/07/1984SE |
| K841751 | Levine Eosin Methylene Blue AgarJSI · Traditional | 05/31/1984SE |
| K841749 | Chocolate AgarKZI · Traditional | 05/31/1984SE |
| K841748 | Sheep Blood AgarKZI · Traditional | 05/31/1984SE |
| K841746 | Salmonella-Shigella AgarJSJ · Traditional | 05/31/1984SE |
| K841755 | Mueller-Hinton AgarJTZ · Traditional | 05/14/1984SE |
| K841745 | Hektoen Enteric AgarJSI · Traditional | 05/11/1984SE |
| K841754 | Columbia Cna AgarJSJ · Traditional | 05/07/1984SE |
Questions and answers
When was Martin-Lewis Agar cleared by the FDA?
Martin-Lewis Agar (K841750) received a 510(k) decision of Substantially Equivalent on May 31, 1984, 34 days after the submission was received.
What is the product code of K841750?
The FDA product code is JTY – Culture Media, For Isolation Of Pathogenic Neisseria, a Class II (moderate risk) device regulated under 21 CFR 866.2410.