Martin Lewis Agar
FDA 510(k) K850722 · Rapid City Regional Hospital, Inc.
510(k) numberK850722
Submission
- Device name
- Martin Lewis Agar
- Applicant
- Rapid City Regional Hospital, Inc.
Rapid City, SD, US - Received
- February 22, 1985
- Decision date
- March 22, 1985
- 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 |
|---|---|---|
| K850724 | Culture Media Nonselective & NondifferentialKZI · Traditional | 03/25/1985SE |
| K850723 | Sabouraud's Dextrose Agar, Bordet Gengou Agar, MycJSI · Traditional | 03/22/1985SE |
| K850721 | Kliger's Iron Agar, Sim Media, MRVP Medium, Bile EJSH · Traditional | 03/22/1985SE |
| K850720 | Eosin Methylene Blue Agar, SS Agar, XLD Agar 6.5%JSI · Traditional | 03/22/1985SE |
| K850719 | Dnase Test Media, Christensen's Urea AgarJSH · Traditional | 03/22/1985SE |
| K850717 | Amies Transport MediaJSM · Traditional | 03/22/1985SE |
| K850716 | Selenite F BrothJSJ · Traditional | 03/22/1985SE |
| K850715 | Mueller Hinton AgarJTZ · Traditional | 03/22/1985SE |
| K850718 | Corn Meal AgarJSH · Traditional | 03/20/1985SE |
Questions and answers
When was Martin Lewis Agar cleared by the FDA?
Martin Lewis Agar (K850722) received a 510(k) decision of Substantially Equivalent on March 22, 1985, 28 days after the submission was received.
What is the product code of K850722?
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.