Kligler Iron Agar Kia
FDA 510(k) K850546 · Hardy Media
510(k) numberK850546
Submission
- Device name
- Kligler Iron Agar Kia
- Applicant
- Hardy Media
Santa Barbara, CA, US - Received
- February 11, 1985
- Decision date
- March 11, 1985
- 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 |
|---|---|---|
| K880134 | Middlebrook 7H11 AgarKZI · Traditional | 03/31/1988SE |
| K880133 | Mil MediumJSE · Traditional | 03/31/1988SE |
| K880131 | Lowenstein-Jensen, GruftKZI · Traditional | 03/31/1988SE |
| K880126 | Lauryl Tryptose BrothJSF · Traditional | 03/31/1988SE |
| K880125 | Lowenstein-Jensen, SelectiveJSI · Traditional | 03/31/1988SE |
| K880124 | Lowenstein-Jensen, W/NaclJSJ · Traditional | 03/31/1988SE |
| K880123 | Lowenstein-Jensen SlantJSJ · Traditional | 03/31/1988SE |
| K880122 | Middlebrook 7H9 BrothKZI · Traditional | 03/31/1988SE |
| K880121 | Moellers Decarboxylase, BaseJSH · Traditional | 03/31/1988SE |
| K880120 | Moellers Decarboxylase, LysineJSF · Traditional | 03/31/1988SE |
Questions and answers
When was Kligler Iron Agar Kia cleared by the FDA?
Kligler Iron Agar Kia (K850546) received a 510(k) decision of Substantially Equivalent on March 11, 1985, 28 days after the submission was received.
What is the product code of K850546?
The FDA product code is JSE – Culture Media, Multiple Biochemical Test, a Class I (low risk) device regulated under 21 CFR 866.2320.