Kligler Iron Agar and Triple Sugar Iron Agar
FDA 510(k) K874537 · Lakewood Biochemical Co., Inc.
510(k) numberK874537
Submission
- Device name
- Kligler Iron Agar and Triple Sugar Iron Agar
- Applicant
- Lakewood Biochemical Co., Inc.
Dallas, TX, US - Received
- November 3, 1987
- Decision date
- November 20, 1987
- 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
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| K880116 | MRVP BrothJSE · Traditional | Hardy Media | 03/31/1988SE |
| K871096 | Cystine Tryptic Agar W/O CarbohydratesJSE · Traditional | bioMerieux, Inc. | 04/03/1987SE |
| K864674 | Microdilution Identification PanelsJSE · Traditional | American Micro Scan | 01/05/1987SE |
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| K860415 | Biotis Simmon Citrate AgarJSE · Traditional | Otisville Biotech, Inc. | 02/24/1986SE |
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| 510(k) | Device | Decision |
|---|---|---|
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| K882351 | Mueller Hinton Agar Plates P3318/1&2/P3418/P34181JTZ · Traditional | 06/28/1988SE |
| K882463 | Potato Dextrose Agar (Pda) - Product #P3421JSJ · Traditional | 06/22/1988SE |
| K882182 | Salmonella-Shigella (SS) Agar - Product #P3326JSI · Traditional | 06/06/1988SE |
| K880947 | Nutrient Agar Plate, Slant Tube and Broth TubeJSG · Traditional | 04/01/1988SE |
| K880946 | Nutrient Gelatin - Product Number T2860JSF · Traditional | 04/01/1988SE |
| K880945 | Camplyobacter Culture Media Products P3873/T3597JSJ · Traditional | 03/30/1988SE |
| K875136 | Columbia Blood Agar P3308/ Columbia Cna P3750JSG · Traditional | 01/12/1988SE |
| K874538 | Todd-Hewitt Broth (0.5ML)#3099 & (5.OML)#T3516JSG · Traditional | 11/20/1987SE |
| K874345 | Tsa W/Neomycin & 5% Sheep Blood - # P3104 & Z3050JSJ · Traditional | 11/06/1987SE |
Questions and answers
When was Kligler Iron Agar and Triple Sugar Iron Agar cleared by the FDA?
Kligler Iron Agar and Triple Sugar Iron Agar (K874537) received a 510(k) decision of Substantially Equivalent on November 20, 1987, 17 days after the submission was received.
What is the product code of K874537?
The FDA product code is JSE – Culture Media, Multiple Biochemical Test, a Class I (low risk) device regulated under 21 CFR 866.2320.