#2008 Simmons Citrate
FDA 510(k) K820809 · Biomedica, Inc.
510(k) numberK820809
Submission
- Device name
- #2008 Simmons Citrate
- 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
- JSF – Culture Media, Single Biochemical Test
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2320
- Specialty
- Microbiology
Other 510(k)s with product code JSF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K880946 | Nutrient Gelatin - Product Number T2860JSF · Traditional | Lakewood Biochemical Co., Inc. | 04/01/1988SE |
| K880126 | Lauryl Tryptose BrothJSF · Traditional | Hardy Media | 03/31/1988SE |
| K880120 | Moellers Decarboxylase, LysineJSF · Traditional | Hardy Media | 03/31/1988SE |
| K880119 | Moellers Decarboxylase, OnithineJSF · Traditional | Hardy Media | 03/31/1988SE |
| K880139 | Onpg Test ReagentJSF · Traditional | Hardy Media | 03/30/1988SE |
| K880135 | Nitrate BrothJSF · Traditional | Hardy Media | 03/30/1988SE |
| K880129 | Brilliant Green Bile BrothJSF · Traditional | Hardy Media | 03/30/1988SE |
| K880118 | Moelloers Decarboxylase, ArginineJSF · Traditional | Hardy Media | 03/30/1988SE |
| K880113 | Cystine Tryptic Medium W/LactoseJSF · Traditional | Hardy Media | 03/30/1988SE |
| K880112 | Cystine Tryptic Medium W/ MaltoseJSF · Traditional | Hardy Media | 03/30/1988SE |
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|---|---|---|
| K820810 | #4004 Triple Sugar Iron Agar Slants-TubeJSE · 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 |
| K820799 | #2002 Mannitol Salt AgarJSJ · Traditional | 04/08/1982SE |
Questions and answers
When was #2008 Simmons Citrate cleared by the FDA?
#2008 Simmons Citrate (K820809) 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 K820809?
The FDA product code is JSF – Culture Media, Single Biochemical Test, a Class I (low risk) device regulated under 21 CFR 866.2320.