Phenylalanine Agar
FDA 510(k) K851346 · Micro Media Laboratories
510(k) numberK851346
Submission
- Device name
- Phenylalanine Agar
- Applicant
- Micro Media Laboratories
San Diego, CA, US - Received
- April 4, 1985
- Decision date
- April 19, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSH – Culture Media, Non-Selective And Differential
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2320
- Specialty
- Microbiology
Other 510(k)s with product code JSH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K881560 | Urea BrothJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881559 | Urea Agar BaseJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881553 | Russell Double Sugar AgarJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881551 | Phenol Red Broth BaseJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881540 | Flo AgarJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881486 | Dnase Test AgarJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K880121 | Moellers Decarboxylase, BaseJSH · Traditional | Hardy Media | 03/31/1988SE |
| K880117 | Of Medium BaseJSH · Traditional | Hardy Media | 03/30/1988SE |
| K873270 | Actinomycete Differential MediaJSH · Traditional | Central Media | 11/04/1987SE |
| K873263 | Maintenance & Carbohydrate Fermentation MediaJSH · Traditional | Central Media | 10/28/1987SE |
More from Central Media
| 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 |
| 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 |
| K850846 | Salt BrothJSJ · Traditional | 03/20/1985SE |
Questions and answers
When was Phenylalanine Agar cleared by the FDA?
Phenylalanine Agar (K851346) received a 510(k) decision of Substantially Equivalent on April 19, 1985, 15 days after the submission was received.
What is the product code of K851346?
The FDA product code is JSH – Culture Media, Non-Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2320.