Kligler Iron Agar
FDA 510(k) K834001 · Micro Media Laboratories
510(k) numberK834001
Submission
- Device name
- Kligler Iron Agar
- Applicant
- Micro Media Laboratories
Mchenry, IL, US - Received
- November 21, 1983
- Decision date
- December 22, 1983
- 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 |
|---|---|---|
| K853691 | Tergitol 7 AgarJSI · Traditional | 09/17/1985SE |
| K853690 | Columbiz Blood AgarJSG · Traditional | 09/17/1985SE |
| K851344 | Oxidative Formentive MediumJSH · Traditional | 04/22/1985SE |
| K851348 | Coba AgarJSJ · Traditional | 04/19/1985SE |
| K851347 | Kanamycin-Vancomycin-Laked Blood AgarJSJ · Traditional | 04/19/1985SE |
| K851346 | Phenylalanine AgarJSH · Traditional | 04/19/1985SE |
| K851345 | Purple BrothJSH · Traditional | 04/19/1985SE |
| K851343 | Brom Cresol Purple StarchJSH · Traditional | 04/19/1985SE |
| K850848 | Brain Heart Infusion AgarJSG · Traditional | 03/20/1985SE |
| K850847 | Thioglycolate Medium W/Vitamin KL & HeminJSG · Traditional | 03/20/1985SE |
Questions and answers
When was Kligler Iron Agar cleared by the FDA?
Kligler Iron Agar (K834001) received a 510(k) decision of Substantially Equivalent on December 22, 1983, 31 days after the submission was received.
What is the product code of K834001?
The FDA product code is JSE – Culture Media, Multiple Biochemical Test, a Class I (low risk) device regulated under 21 CFR 866.2320.