Tergitol 7 Agar with TTC
FDA 510(k) K821775 · Granite Diagnostics, Inc.
510(k) numberK821775
Submission
- Device name
- Tergitol 7 Agar with TTC
- Applicant
- Granite Diagnostics, Inc.
Mchenry, IL, US - Received
- June 17, 1982
- Decision date
- July 2, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSI – Culture Media, Selective And Differential
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2360
- Specialty
- Microbiology
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| K882182 | Salmonella-Shigella (SS) Agar - Product #P3326JSI · Traditional | Lakewood Biochemical Co., Inc. | 06/06/1988SE |
| K881577 | Modified Selective Streptococcus AgarJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881576 | Selenite BrothJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881575 | Selective Streptococcus AgarJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881572 | XL Agar BaseJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881556 | Trichomonas BrothJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
More from Acumedia Manufacturers, Inc.
| 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 Tergitol 7 Agar with TTC cleared by the FDA?
Tergitol 7 Agar with TTC (K821775) received a 510(k) decision of Substantially Equivalent on July 2, 1982, 15 days after the submission was received.
What is the product code of K821775?
The FDA product code is JSI – Culture Media, Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.