P.E.Z. Agar (Phenylethanol Agar)
FDA 510(k) K854453 · R. Kent Richards, Inc.
510(k) numberK854453
Submission
- Device name
- P.E.Z. Agar (Phenylethanol 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
- JSJ – Culture Media, Selective And Non-Differential
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2360
- Specialty
- Microbiology
Other 510(k)s with product code JSJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K882463 | Potato Dextrose Agar (Pda) - Product #P3421JSJ · Traditional | Lakewood Biochemical Co., Inc. | 06/22/1988SE |
| K881578 | StreptoselJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881574 | W-L Differential MediumJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881573 | Phytone Yeast Extract AgarJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881571 | Ym BrothJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881570 | Sabouraud Maltose AgarJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881565 | Inhibitory Mold AgarJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881561 | Tergitol 7 BrothJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881549 | Mycological Agar W/Low PHJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881547 | Mitis Salivarius AgarJSJ · 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 |
| 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 |
| K854449 | Hektoen Enteric AgarJSI · Traditional | 11/18/1985SE |
| K854275 | Thayer-Martin Medium (Mod)JTY · Traditional | 11/12/1985SE |
Questions and answers
When was P.E.Z. Agar (Phenylethanol Agar) cleared by the FDA?
P.E.Z. Agar (Phenylethanol Agar) (K854453) 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 K854453?
The FDA product code is JSJ – Culture Media, Selective And Non-Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.