Strep-Kit
FDA 510(k) K850765 · Culture Kits, Inc.
510(k) numberK850765
Submission
- Device name
- Strep-Kit
- Applicant
- Culture Kits, Inc.
Norwich, NY, US - Received
- February 25, 1985
- Decision date
- April 24, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSJ – Culture Media, Selective And Non-Differential
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2360
- Specialty
- Microbiology
Other 510(k)s with product code JSJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K882463 | Potato Dextrose Agar (Pda) - Product #P3421JSJ · Traditional | Lakewood Biochemical Co., Inc. | 06/22/1988SE |
| K881578 | StreptoselJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881574 | W-L Differential MediumJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881573 | Phytone Yeast Extract AgarJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881571 | Ym BrothJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881570 | Sabouraud Maltose AgarJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881565 | Inhibitory Mold AgarJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881561 | Tergitol 7 BrothJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881549 | Mycological Agar W/Low PHJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881547 | Mitis Salivarius AgarJSJ · 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 |
| K854672 | Candi-Kit TMJSI · Traditional | 07/11/1986SE |
| 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 |
| K850998 | Uri-KitJSG · Traditional | 04/01/1985SE |
Questions and answers
When was Strep-Kit cleared by the FDA?
Strep-Kit (K850765) received a 510(k) decision of Substantially Equivalent on April 24, 1985, 58 days after the submission was received.
What is the product code of K850765?
The FDA product code is JSJ – Culture Media, Selective And Non-Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.