Tryptic Soy Agar W/ 5% Horse Blood
FDA 510(k) K790375 · Granite Diagnostics, Inc.
510(k) numberK790375
Submission
- Device name
- Tryptic Soy Agar W/ 5% Horse Blood
- Applicant
- Granite Diagnostics, Inc.
Mchenry, IL, US - Received
- February 23, 1979
- Decision date
- March 15, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSG – Culture Media, Non-Selective And Non-Differential
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2300
- Specialty
- Microbiology
Other 510(k)s with product code JSG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K882495 | Thioglycollate Broth W/Vita. K & Hemin - #T3007JSG · Traditional | Lakewood Biochemical Co., Inc. | 07/01/1988SE |
| K881564 | Tryptose Blood Agar Base W/Yeast ExtractJSG · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881563 | Tryptose Phosphate BrothJSG · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881562 | Tryptose Blood Agar BaseJSG · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881558 | Tryptose AgarJSG · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881557 | TryptoneJSG · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881554 | Skim Milk DehydratedJSG · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881550 | Of Basal MediumJSG · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881548 | MPH AgarJSG · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881546 | Malt Extract AgarJSG · 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 Tryptic Soy Agar W/ 5% Horse Blood cleared by the FDA?
Tryptic Soy Agar W/ 5% Horse Blood (K790375) received a 510(k) decision of Substantially Equivalent on March 15, 1979, 20 days after the submission was received.
What is the product code of K790375?
The FDA product code is JSG – Culture Media, Non-Selective And Non-Differential, a Class I (low risk) device regulated under 21 CFR 866.2300.