Hektoen Enteric Agar
FDA 510(k) K854449 · R. Kent Richards, Inc.
510(k) numberK854449
Submission
- Device name
- Hektoen Enteric Agar
- Applicant
- R. Kent Richards, Inc.
Pl. Grove, UT, US - Received
- November 5, 1985
- Decision date
- November 18, 1985
- 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
Other 510(k)s with product code JSI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K070691 | BBL Chromagar 0157JSI · Traditional | Becton, Dickinson & CO | 11/20/2007SE |
| K974428 | DipstreakJSI · Traditional | Novamed , Ltd. | 07/30/1998SE |
| K891593 | Listeria Selective Enrichment MediumJSI · Traditional | Oxoid U.S.A., Inc. | 06/09/1989SE |
| K890199 | Dentocult Sm-Strip MutansJSI · Traditional | Orion Corp. | 03/02/1989SE |
| 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 |
More from Acumedia Manufacturers, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K871065 | Chlamydia & Viral Transport MediumJSM · Traditional | 04/14/1987SE |
| K854457 | Columbia Cna Agar W/5% Sheep BloodJSJ · Traditional | 11/18/1985SE |
| K854456 | Campylobacter Blood AgarJSJ · Traditional | 11/18/1985SE |
| K854455 | CDC Anaerobe Blood AgarJSG · Traditional | 11/18/1985SE |
| K854454 | Tryptic Soy Blood AgarKZI · Traditional | 11/18/1985SE |
| K854453 | P.E.Z. Agar (Phenylethanol Agar)JSJ · Traditional | 11/18/1985SE |
| K854452 | Mannitol Salt AgarJSI · Traditional | 11/18/1985SE |
| K854451 | Mueller Hinton MediumJTZ · Traditional | 11/18/1985SE |
| K854450 | Bile Esculin Azide AgarJSI · Traditional | 11/18/1985SE |
| K854275 | Thayer-Martin Medium (Mod)JTY · Traditional | 11/12/1985SE |
Questions and answers
When was Hektoen Enteric Agar cleared by the FDA?
Hektoen Enteric Agar (K854449) received a 510(k) decision of Substantially Equivalent on November 18, 1985, 13 days after the submission was received.
What is the product code of K854449?
The FDA product code is JSI – Culture Media, Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.