Streptococus Id Plate
FDA 510(k) K831349 · Granite Diagnostics, Inc.
510(k) numberK831349
Submission
- Device name
- Streptococus Id Plate
- Applicant
- Granite Diagnostics, Inc.
Mchenry, IL, US - Received
- April 25, 1983
- Decision date
- May 16, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JST – Kit, Fastidious Organisms
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
Other 510(k)s with product code JST
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K962423 | Bblcrystal Neisseria/Haemophilus (N/H) SystemJST · Traditional | Becton Dickinson Microbiology Systems | 08/02/1996SE |
| K854732 | Api 50 CHB (Culture Media)JST · Traditional | Dms Products, Inc. | 03/04/1986SE |
| K841661 | Synthetic Broth A.O.A.C.JST · Traditional | Oxoid U.S.A., Inc. | 05/11/1984SE |
| K832239 | Rim-Haemophilus 2JST · Traditional | Austin Biological Laboratories | 08/12/1983SE |
| K832051 | Rim-Haemophilus 1 & 2JST · Traditional | Austin Biological Laboratories | 08/12/1983SE |
More from Austin Biological Laboratories
| 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 |
| 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 |
| K822997 | Strep Selective AgarJSI · Traditional | 11/17/1982SE |
Questions and answers
When was Streptococus Id Plate cleared by the FDA?
Streptococus Id Plate (K831349) received a 510(k) decision of Substantially Equivalent on May 16, 1983, 21 days after the submission was received.
What is the product code of K831349?
The FDA product code is JST – Kit, Fastidious Organisms, a Class I (low risk) device regulated under 21 CFR 866.2660.