Mycological Agar W/Antibiotics
FDA 510(k) K844931 · American Laboratory Supply, Inc.
510(k) numberK844931
Submission
- Device name
- Mycological Agar W/Antibiotics
- Applicant
- American Laboratory Supply, Inc.
Burlington, NC, US - Received
- December 19, 1984
- Decision date
- February 27, 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 |
|---|---|---|
| K852578 | Cled AgarJSH · Traditional | 07/12/1985SE |
| K844933 | Bile Esculin AgarJSI · Traditional | 02/27/1985SE |
| K844932 | Malt AgarJSJ · Traditional | 02/27/1985SE |
| K844930 | Brillant Green AgarJSI · Traditional | 02/27/1985SE |
| K844929 | Inhibitory Mold AgarJSJ · Traditional | 02/27/1985SE |
| K844934 | Azide Agar W/5% Sheep BloodJSI · Traditional | 02/25/1985SE |
| K820562 | Campylobacter Selective MediumJSJ · Traditional | 03/19/1982SE |
| K820561 | Sabouraud Dextrose AgarJSJ · Traditional | 03/19/1982SE |
| K820560 | Phenylethanol Agar W/5% Sheep BloodJSJ · Traditional | 03/19/1982SE |
| K820559 | Anaerobe Blood AgarJSG · Traditional | 03/19/1982SE |
Questions and answers
When was Mycological Agar W/Antibiotics cleared by the FDA?
Mycological Agar W/Antibiotics (K844931) received a 510(k) decision of Substantially Equivalent on February 27, 1985, 70 days after the submission was received.
What is the product code of K844931?
The FDA product code is JSJ – Culture Media, Selective And Non-Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.