Agar P
FDA 510(k) K823102 · Dms Laboratories
510(k) numberK823102
Submission
- Device name
- Agar P
- Applicant
- Dms Laboratories
Mchenry, IL, US - Received
- October 20, 1982
- Decision date
- December 3, 1982
- 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 |
|---|---|---|
| K831187 | TRPJTO · Traditional | 05/09/1983SE |
| K831186 | Rapid NFTJSN · Traditional | 05/09/1983SE |
| K830437 | CHSJSC · Traditional | 03/17/1983SE |
| K821038 | Fast Violet BJTS · Traditional | 05/27/1982SE |
| K813613 | Rapid CHJTO · Traditional | 02/22/1982SE |
| K813612 | Rapid ZymeJTO · Traditional | 02/22/1982SE |
| K820213 | Saline SolutionJTO · Traditional | 02/12/1982SE |
| K820212 | OxiJTO · Traditional | 02/12/1982SE |
| K820211 | NinhydrinJTO · Traditional | 02/12/1982SE |
| K820210 | IndJTO · Traditional | 02/12/1982SE |
Questions and answers
When was Agar P cleared by the FDA?
Agar P (K823102) received a 510(k) decision of Substantially Equivalent on December 3, 1982, 44 days after the submission was received.
What is the product code of K823102?
The FDA product code is JSJ – Culture Media, Selective And Non-Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.