Decarboxylase Moeller Base with or With-
FDA 510(k) K792425 · Isle Media and Sterile Products, Inc.
510(k) numberK792425
Submission
- Device name
- Decarboxylase Moeller Base with or With-
- Applicant
- Isle Media and Sterile Products, Inc.
Mchenry, IL, US - Received
- November 27, 1979
- Decision date
- December 27, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSE – Culture Media, Multiple Biochemical Test
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2320
- Specialty
- Microbiology
Other 510(k)s with product code JSE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K962265 | MLX Microtiter Plate LuminometerJSE · Traditional | Dynatech Laboratories, Inc. | 07/25/1996SE |
| K883996 | X-Act Ldc/IndJSE · Traditional | Pro-Lab, Inc. | 10/12/1988SE |
| K883995 | X-Act Urea/TdaJSE · Traditional | Pro-Lab, Inc. | 10/12/1988SE |
| K880133 | Mil MediumJSE · Traditional | Hardy Media | 03/31/1988SE |
| K880116 | MRVP BrothJSE · Traditional | Hardy Media | 03/31/1988SE |
| K874537 | Kligler Iron Agar and Triple Sugar Iron AgarJSE · Traditional | Lakewood Biochemical Co., Inc. | 11/20/1987SE |
| K871096 | Cystine Tryptic Agar W/O CarbohydratesJSE · Traditional | bioMerieux, Inc. | 04/03/1987SE |
| K864674 | Microdilution Identification PanelsJSE · Traditional | American Micro Scan | 01/05/1987SE |
| K862393 | Biotis Litmus MilkJSE · Traditional | Otisville Biotech, Inc. | 07/03/1986SE |
| K860415 | Biotis Simmon Citrate AgarJSE · Traditional | Otisville Biotech, Inc. | 02/24/1986SE |
More from Otisville Biotech, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K831671 | Modified Soybean Casein Digest BrothJSG · Traditional | 07/28/1983SE |
| K821218 | Campy-S AgarJSJ · Traditional | 05/14/1982SE |
| K820863 | Media for In-Vitro Diagnostic UseJSJ · Traditional | 04/16/1982SE |
| K812798 | Motility Gi MediumJSG · Traditional | 10/20/1981SE |
| K812797 | Schaedler AgarsJSG · Traditional | 10/20/1981SE |
| K812796 | Anaerobic Cna Blood AgarJSJ · Traditional | 10/20/1981SE |
| K812795 | Anaerobic Blood AgarJSG · Traditional | 10/20/1981SE |
| K800818 | Chlamydospore AgarJSH · Traditional | 04/24/1980SE |
| K800807 | Corn Meal Agar MediaJSJ · Traditional | 04/24/1980SE |
| K800334 | Martin-Lewis AgarJTY · Traditional | 03/03/1980SE |
Questions and answers
When was Decarboxylase Moeller Base with or With- cleared by the FDA?
Decarboxylase Moeller Base with or With- (K792425) received a 510(k) decision of Substantially Equivalent on December 27, 1979, 30 days after the submission was received.
What is the product code of K792425?
The FDA product code is JSE – Culture Media, Multiple Biochemical Test, a Class I (low risk) device regulated under 21 CFR 866.2320.