#2007 XLD
FDA 510(k) K820801 · Biomedica, Inc.
510(k) numberK820801
Submission
- Device name
- #2007 XLD
- 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
- JSI – Culture Media, Selective And Differential
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2360
- Specialty
- Microbiology
Other 510(k)s with product code JSI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K070691 | BBL Chromagar 0157JSI · Traditional | Becton, Dickinson & CO | 11/20/2007SE |
| K974428 | DipstreakJSI · Traditional | Novamed , Ltd. | 07/30/1998SE |
| K891593 | Listeria Selective Enrichment MediumJSI · Traditional | Oxoid U.S.A., Inc. | 06/09/1989SE |
| K890199 | Dentocult Sm-Strip MutansJSI · Traditional | Orion Corp. | 03/02/1989SE |
| K882182 | Salmonella-Shigella (SS) Agar - Product #P3326JSI · Traditional | Lakewood Biochemical Co., Inc. | 06/06/1988SE |
| K881577 | Modified Selective Streptococcus AgarJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881576 | Selenite BrothJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881575 | Selective Streptococcus AgarJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881572 | XL Agar BaseJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881556 | Trichomonas BrothJSI · 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 |
| K820800 | #2006 Salmonella Shigella AgarJSI · Traditional | 04/08/1982SE |
| K820799 | #2002 Mannitol Salt AgarJSJ · Traditional | 04/08/1982SE |
Questions and answers
When was #2007 XLD cleared by the FDA?
#2007 XLD (K820801) 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 K820801?
The FDA product code is JSI – Culture Media, Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.