Hektoen Enteric Agar Plate
FDA 510(k) K832535 · Otisville Biotech, Inc.
510(k) numberK832535
Submission
- Device name
- Hektoen Enteric Agar Plate
- Applicant
- Otisville Biotech, Inc.
Walker, MI, US - Received
- July 29, 1983
- Decision date
- October 4, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSI – Culture Media, Selective And Differential
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2360
- Specialty
- Microbiology
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| K882182 | Salmonella-Shigella (SS) Agar - Product #P3326JSI · Traditional | Lakewood Biochemical Co., Inc. | 06/06/1988SE |
| K881577 | Modified Selective Streptococcus AgarJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881576 | Selenite BrothJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881575 | Selective Streptococcus AgarJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881572 | XL Agar BaseJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881556 | Trichomonas BrothJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
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| 510(k) | Device | Decision |
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| K862398 | Biotis Decarboxylase Media, OrnithineJSF · Traditional | 07/03/1986SE |
| K862397 | Biotis Decarboxylase Media, LysineJSF · Traditional | 07/03/1986SE |
| K862396 | Biotis Decarboxylase Media, ArginineJSF · Traditional | 07/03/1986SE |
| K862395 | Biotis Decarboxylase Media, BaseJSH · Traditional | 07/03/1986SE |
| K862394 | Biotis Mitis SalivariusJSI · Traditional | 07/03/1986SE |
| K862393 | Biotis Litmus MilkJSE · Traditional | 07/03/1986SE |
| K862392 | Biotis Motility Test MediumJSF · Traditional | 07/03/1986SE |
| K862391 | Biotis Desoxycholate AgarJSI · Traditional | 07/03/1986SE |
Questions and answers
When was Hektoen Enteric Agar Plate cleared by the FDA?
Hektoen Enteric Agar Plate (K832535) received a 510(k) decision of Substantially Equivalent on October 4, 1983, 67 days after the submission was received.
What is the product code of K832535?
The FDA product code is JSI – Culture Media, Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.