Granite Diagnostics, Inc.
Medical device manufacturer in Burlington, NC.
47510(k) clearances
0PMA approvals
0recalls
Device types
- JSJ Culture Media, Selective And Non-Differential 10
- JSI Culture Media, Selective And Differential 8
- JSF Culture Media, Single Biochemical Test 7
- JTY Culture Media, For Isolation Of Pathogenic… 6
- JSH Culture Media, Non-Selective And Differential 5
- JSG Culture Media, Non-Selective And… 2
- JSD Culture Media, Selective Broth 2
- JSE Culture Media, Multiple Biochemical Test 2
- JSC Culture Media, General Nutrient Broth 1
- HYI Iodine, Grams 1
- JWX Kit, Screening, Staphylococcus Aureus 1
- JXA Kit, Screening, Urine 1
- JST Kit, Fastidious Organisms 1
510(k) clearances
| 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 |
| K822997 | Strep Selective AgarJSI · Traditional | 11/17/1982SE |
| K823001 | Peptone Iron AgarJSF · Traditional | 11/16/1982SE |
| K823000 | Macate BrothJSF · Traditional | 11/16/1982SE |
| K822999 | Dnase Test Agar W/Toluidine BlueJSF · Traditional | 11/16/1982SE |
| K822998 | Christensens Citrate Sulfide AgarJSE · Traditional | 11/16/1982SE |
| K822996 | Jordans Tartrate AgarJSF · Traditional | 11/16/1982SE |
| K822995 | Andrades Fermentation MediaJSF · Traditional | 11/16/1982SE |
| K822994 | Corn Meal Agar W/Polysorbate 80JSJ · Traditional | 11/16/1982SE |
| K823091 | H BrothJSH · Traditional | 11/05/1982SE |
| K823072 | Lecithin Lactose AgarJSE · Traditional | 11/05/1982SE |
| K823071 | Rice Extract AgarJSH · Traditional | 11/05/1982SE |
| K823070 | Acetamide Agar SlantJSH · Traditional | 11/05/1982SE |
| K822855 | Yersinia Isolation MediumJSI · Traditional | 11/05/1982SE |
| K822702 | V AgarJSH · Traditional | 09/30/1982SE |
| K822694 | Yeast Assimilation BrothJSF · Traditional | 09/30/1982SE |
| K822527 | Anaerobe Pea PlateJSJ · Traditional | 09/30/1982SE |
| K822559 | SXT Blood AgarJSJ · Traditional | 09/14/1982SE |
| K822558 | LSM AgarJWX · Traditional | 09/14/1982SE |
| K822377 | Haemophilus Id PlateJSH · Traditional | 08/25/1982SE |
| K822131 | Dermatophyte Test MediumJSD · Traditional | 08/03/1982SE |
| K821977 | Gramstain SetHYI · Traditional | 07/22/1982SE |
| K821864 | Thioglycollate Med. W/Vitamin K-1JSC · Traditional | 07/13/1982SE |
| K821845 | Egg Yolk Agar (Plate)JSF · Traditional | 07/08/1982SE |
| K821775 | Tergitol 7 Agar with TTCJSI · Traditional | 07/02/1982SE |
| K821493 | Littman Oxgal AgarJSJ · Traditional | 06/01/1982SE |
| K812451 | Campy Thioglycollate (Tube)JSD · Traditional | 09/23/1981SE |
| K810961 | Campylobacter Med. (Plate)JSJ · Traditional | 05/05/1981SE |
| K802397 | Anaerobe Blood AgarJSG · Traditional | 10/23/1980SE |
| K790375 | Tryptic Soy Agar W/ 5% Horse BloodJSG · Traditional | 03/15/1979SE |
| K780704 | Columbia Agar with 5% Rabbit BloodJSI · Traditional | 05/12/1978SE |
| K771872 | Martin Lewis TransgrowJTY · Traditional | 10/25/1977SE |
| K771871 | Martin Lewis Agar (Plate)JTY · Traditional | 10/25/1977SE |
| K771870 | Martin Lewis Agar (Jembec)JTY · Traditional | 10/25/1977SE |
| K771661 | Middlebrook 7H11 Agar (Plate)JSJ · Traditional | 09/12/1977SE |
| K770874 | Improved Thayer Martin (Plate)JTY · Traditional | 06/08/1977SE |
| K770876 | Improved TransgrowJTY · Traditional | 06/03/1977SE |
| K770875 | Improved Thayer Martin (Jembec)JTY · Traditional | 06/03/1977SE |