Culture Media, Selective & Differential
FDA 510(k) K820844 · Blue Ridge Media Co.
510(k) numberK820844
Submission
- Device name
- Culture Media, Selective & Differential
- Applicant
- Blue Ridge Media Co.
Walker, MI, US - Received
- March 26, 1982
- Decision date
- April 16, 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K820849 | Blue Ridge Rabbit BloodLHW · Traditional | 04/16/1982SE |
| K820848 | Blue Ridge Sheep BloodLHW · Traditional | 04/16/1982SE |
| K820847 | Isolation of Pathogenic NeisseriaJTY · Traditional | 04/16/1982SE |
| K820846 | Antimicrobial Suscep. Test, MuellerJTZ · Traditional | 04/16/1982SE |
| K820845 | Dulture Media, Selective & Non-DifferJSJ · Traditional | 04/16/1982SE |
| K820843 | Culture Media Selective BrothJSD · Traditional | 04/16/1982SE |
| K820842 | Culture Media, Non-Selective/DifferJSE · Traditional | 04/16/1982SE |
| K820841 | Culture Media, Multiple BiochemicalJSE · Traditional | 04/16/1982SE |
| K820840 | Culture Media, General Nutrient BrothJSC · Traditional | 04/16/1982SE |
| K820839 | Culture Media, Single Biochem. TestJSF · Traditional | 04/16/1982SE |
Questions and answers
When was Culture Media, Selective & Differential cleared by the FDA?
Culture Media, Selective & Differential (K820844) received a 510(k) decision of Substantially Equivalent on April 16, 1982, 21 days after the submission was received.
What is the product code of K820844?
The FDA product code is JSI – Culture Media, Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.