Culture Media, Single Biochem. Test
FDA 510(k) K820839 · Blue Ridge Media Co.
510(k) numberK820839
Submission
- Device name
- Culture Media, Single Biochem. Test
- Applicant
- Blue Ridge Media Co.
Mchenry, IL, US - Received
- March 26, 1982
- Decision date
- April 16, 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 |
More from Hardy Media
| 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 |
| K820844 | Culture Media, Selective & DifferentialJSI · 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 |
Questions and answers
When was Culture Media, Single Biochem. Test cleared by the FDA?
Culture Media, Single Biochem. Test (K820839) 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 K820839?
The FDA product code is JSF – Culture Media, Single Biochemical Test, a Class I (low risk) device regulated under 21 CFR 866.2320.