Candi-Kit TM
FDA 510(k) K854672 · Culture Kits, Inc.
510(k) numberK854672
Submission
- Device name
- Candi-Kit TM
- Applicant
- Culture Kits, Inc.
Norwich, NY, US - Received
- November 21, 1985
- Decision date
- July 11, 1986
- 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
Other 510(k)s with product code JSI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K070691 | BBL Chromagar 0157JSI · Traditional | Becton, Dickinson & CO | 11/20/2007SE |
| K974428 | DipstreakJSI · Traditional | Novamed , Ltd. | 07/30/1998SE |
| K891593 | Listeria Selective Enrichment MediumJSI · Traditional | Oxoid U.S.A., Inc. | 06/09/1989SE |
| K890199 | Dentocult Sm-Strip MutansJSI · Traditional | Orion Corp. | 03/02/1989SE |
| 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 |
|---|---|---|
| K911846 | Uri-Three(Tm), ModificationJXA · Traditional | 10/04/1991SE |
| K853488 | Staph KitJSI · Traditional | 08/28/1985SE |
| K851225 | Urine DuoJTZ · Traditional | 08/13/1985SE |
| K852582 | Goni-KitJSX · Traditional | 07/12/1985SE |
| K852480 | Derm-KitJSI · Traditional | 07/09/1985SE |
| K851518 | Mueller Hinton Sensitivity PlateJTZ · Traditional | 04/29/1985SE |
| K850765 | Strep-KitJSJ · Traditional | 04/24/1985SE |
| K850998 | Uri-KitJSG · Traditional | 04/01/1985SE |
Questions and answers
When was Candi-Kit TM cleared by the FDA?
Candi-Kit TM (K854672) received a 510(k) decision of Substantially Equivalent on July 11, 1986, 232 days after the submission was received.
What is the product code of K854672?
The FDA product code is JSI – Culture Media, Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.