Martin Lewis Transgrow
FDA 510(k) K771872 · Granite Diagnostics, Inc.
510(k) numberK771872
Submission
- Device name
- Martin Lewis Transgrow
- Applicant
- Granite Diagnostics, Inc.
Mchenry, IL, US - Received
- October 4, 1977
- Decision date
- October 25, 1977
- 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 |
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| K850969 | Inhibitory Mold Agar PlateJSJ · Traditional | 03/29/1985SE |
| K833254 | Streptococcus Id Triplate SystemJSI · Traditional | 10/28/1983SE |
| K832365 | TCBS AgarJSI · Traditional | 09/01/1983SE |
| K831349 | Streptococus Id PlateJST · Traditional | 05/16/1983SE |
| K830252 | Dipchex Dip-Slide Culture SysJXA · Traditional | 03/07/1983SE |
| K830251 | Campy Blood Agar PlateJSI · Traditional | 02/28/1983SE |
| K823248 | Schaedler AgarsJSJ · Traditional | 12/03/1982SE |
| K823139 | Smith's MediumJSJ · Traditional | 12/03/1982SE |
| K823122 | Laked Blood Agar W/Paromomycin & VancomJSI · Traditional | 12/03/1982SE |
Questions and answers
When was Martin Lewis Transgrow cleared by the FDA?
Martin Lewis Transgrow (K771872) received a 510(k) decision of Substantially Equivalent on October 25, 1977, 21 days after the submission was received.
What is the product code of K771872?
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.