Dermatophyte Test Medium
FDA 510(k) K822131 · Granite Diagnostics, Inc.
510(k) numberK822131
Submission
- Device name
- Dermatophyte Test Medium
- Applicant
- Granite Diagnostics, Inc.
Mchenry, IL, US - Received
- July 19, 1982
- Decision date
- August 3, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSD – Culture Media, Selective Broth
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2360
- Specialty
- Microbiology
Other 510(k)s with product code JSD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K883075 | Fastidious Inoculum BrothJSD · Traditional | Baxter Healthcare Corp | 08/15/1988SE |
| K880107 | Campy BrothJSD · Traditional | Hardy Media | 03/30/1988SE |
| K873324 | Sabouraud Dextrose (SD) Broth Tube, #T3331JSD · Traditional | Lakewood Biochemical Co., Inc. | 10/02/1987SE |
| K873218 | Brain Heart Infusion Broth W/6.5% NAC1 - #T3802JSD · Traditional | Lakewood Biochemical Co., Inc. | 09/23/1987SE |
| K871640 | Alkaline Peptone WaterJSD · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 05/13/1987SE |
| K871447 | Todd Hewitt W/Cna (Lim Broth)JSD · Traditional | Remel Co. | 05/13/1987SE |
| K870594 | T9802 TSB W/6.5% NaclJSD · Traditional | Lakewood Biochemical Co., Inc. | 03/30/1987SE |
| K853609 | Apl Tryptic Soy BrothJSD · Traditional | Apl Medical Supplies | 09/12/1985SE |
| K844547 | Tryptic Soy Broth W/6.5%SODIUM ChlorideJSD · Traditional | bioMerieux, Inc. | 01/16/1985SE |
| K841836 | Selective Culture Med. TrichomonasJSD · Traditional | Microline Scientific | 05/14/1984SE |
More from Microline Scientific
| 510(k) | Device | Decision |
|---|---|---|
| K850970 | Brain Heart Infusion Agar W/5% Sheep Blood, ChloraJSJ · Traditional | 03/29/1985SE |
| 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 Dermatophyte Test Medium cleared by the FDA?
Dermatophyte Test Medium (K822131) received a 510(k) decision of Substantially Equivalent on August 3, 1982, 15 days after the submission was received.
What is the product code of K822131?
The FDA product code is JSD – Culture Media, Selective Broth, a Class I (low risk) device regulated under 21 CFR 866.2360.