#2002 Mannitol Salt Agar
FDA 510(k) K820799 · Biomedica, Inc.
510(k) numberK820799
Submission
- Device name
- #2002 Mannitol Salt Agar
- Applicant
- Biomedica, Inc.
Mchenry, IL, US - Received
- March 23, 1982
- Decision date
- April 8, 1982
- 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
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| 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 |
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| 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 |
|---|---|---|
| K820810 | #4004 Triple Sugar Iron Agar Slants-TubeJSE · Traditional | 04/08/1982SE |
| K820809 | #2008 Simmons CitrateJSF · Traditional | 04/08/1982SE |
| K820807 | #2011 Strep Selective AgarJSJ · Traditional | 04/08/1982SE |
| K820806 | #2004 Phenylethyl Alchol Agar W/Sheep BLJSJ · Traditional | 04/08/1982SE |
| K820805 | #2005 Sabouraud Dextrose AGAR/#4002 SlaJSJ · Traditional | 04/08/1982SE |
| K820804 | #2013 Cna 5% Sheep BloodJSJ · Traditional | 04/08/1982SE |
| K820803 | #2003 Mycobiotic AgarJSJ · Traditional | 04/08/1982SE |
| K820802 | #2009 Biggy AgarJSI · Traditional | 04/08/1982SE |
| K820801 | #2007 XLDJSI · Traditional | 04/08/1982SE |
| K820800 | #2006 Salmonella Shigella AgarJSI · Traditional | 04/08/1982SE |
Questions and answers
When was #2002 Mannitol Salt Agar cleared by the FDA?
#2002 Mannitol Salt Agar (K820799) received a 510(k) decision of Substantially Equivalent on April 8, 1982, 16 days after the submission was received.
What is the product code of K820799?
The FDA product code is JSJ – Culture Media, Selective And Non-Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.