Thayer Martin Agar
FDA 510(k) K864253 · Mds Laboratories, Inc.
510(k) numberK864253
Submission
- Device name
- Thayer Martin Agar
- Applicant
- Mds Laboratories, Inc.
L5j 2m4, CA - Received
- October 28, 1986
- Decision date
- March 31, 1987
- 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 |
|---|---|---|
| K864256 | Tryptone Water (1%)JSF · Traditional | 03/31/1987SE |
| K864255 | Trypticase Soy BrothJSG · Traditional | 03/31/1987SE |
| K864254 | Thioglycollate BrothJSG · Traditional | 03/31/1987SE |
| K864252 | Thayer-Martin JembecJTY · Traditional | 03/31/1987SE |
| K864251 | Selenite F. BrothJSJ · Traditional | 03/31/1987SE |
| K864250 | Sabouraud Dextrose AgarJSJ · Traditional | 03/31/1987SE |
| K864249 | Normal Saline SterileLIB · Traditional | 03/31/1987SE |
| K864248 | Mueller Hinton Agar - SupplementedJTZ · Traditional | 03/31/1987SE |
| K864247 | Mueller Hinton Agar with 5% Sheep BloodJTZ · Traditional | 03/31/1987SE |
| K864246 | Mueller Hinton Agar LargeJTZ · Traditional | 03/31/1987SE |
Questions and answers
When was Thayer Martin Agar cleared by the FDA?
Thayer Martin Agar (K864253) received a 510(k) decision of Substantially Equivalent on March 31, 1987, 154 days after the submission was received.
What is the product code of K864253?
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.