H Broth
FDA 510(k) K823091 · Granite Diagnostics, Inc.
510(k) numberK823091
Submission
- Device name
- H Broth
- Applicant
- Granite Diagnostics, Inc.
Mchenry, IL, US - Received
- October 19, 1982
- Decision date
- November 5, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSH – Culture Media, Non-Selective And Differential
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2320
- Specialty
- Microbiology
Other 510(k)s with product code JSH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K881560 | Urea BrothJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881559 | Urea Agar BaseJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881553 | Russell Double Sugar AgarJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881551 | Phenol Red Broth BaseJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881540 | Flo AgarJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881486 | Dnase Test AgarJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K880121 | Moellers Decarboxylase, BaseJSH · Traditional | Hardy Media | 03/31/1988SE |
| K880117 | Of Medium BaseJSH · Traditional | Hardy Media | 03/30/1988SE |
| K873270 | Actinomycete Differential MediaJSH · Traditional | Central Media | 11/04/1987SE |
| K873263 | Maintenance & Carbohydrate Fermentation MediaJSH · Traditional | Central Media | 10/28/1987SE |
More from Central Media
| 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 H Broth cleared by the FDA?
H Broth (K823091) received a 510(k) decision of Substantially Equivalent on November 5, 1982, 17 days after the submission was received.
What is the product code of K823091?
The FDA product code is JSH – Culture Media, Non-Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2320.