Dermatophyte Test Medium
FDA 510(k) K834010 · Micro Media Laboratories
510(k) numberK834010
Submission
- Device name
- Dermatophyte Test Medium
- Applicant
- Micro Media Laboratories
Mchenry, IL, US - Received
- November 21, 1983
- Decision date
- January 3, 1984
- 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 |
|---|---|---|
| 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 |
| K851346 | Phenylalanine AgarJSH · 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 |
Questions and answers
When was Dermatophyte Test Medium cleared by the FDA?
Dermatophyte Test Medium (K834010) received a 510(k) decision of Substantially Equivalent on January 3, 1984, 43 days after the submission was received.
What is the product code of K834010?
The FDA product code is JSJ – Culture Media, Selective And Non-Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.