Differential Culture Medium
FDA 510(k) K850734 · Roseville Medical Laboratoriesu
510(k) numberK850734
Submission
- Device name
- Differential Culture Medium
- Applicant
- Roseville Medical Laboratoriesu
Roseville, CA, US - Received
- February 20, 1985
- Decision date
- March 20, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSE – Culture Media, Multiple Biochemical Test
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2320
- Specialty
- Microbiology
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| K862393 | Biotis Litmus MilkJSE · Traditional | Otisville Biotech, Inc. | 07/03/1986SE |
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More from Otisville Biotech, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K850738 | Supplement for Culture MediumJSK · Traditional | 03/20/1985SE |
| K850737 | Transport Culture MediumPPM · Traditional | 03/20/1985SE |
| K850736 | Selective Culture MediumJSI · Traditional | 03/20/1985SE |
| K850733 | Multipurpose Culture MediumJSG · Traditional | 03/20/1985SE |
| K850732 | Culture Medium for Pathogenic Neisseria Ssp.MiJTY · Traditional | 03/20/1985SE |
| K850731 | Culture Medium for Antimicrobial Suscep. TestingJTZ · Traditional | 03/20/1985SE |
| K850735 | Enriched Culture MediumKZI · Traditional | 03/16/1985SE |
Questions and answers
When was Differential Culture Medium cleared by the FDA?
Differential Culture Medium (K850734) received a 510(k) decision of Substantially Equivalent on March 20, 1985, 28 days after the submission was received.
What is the product code of K850734?
The FDA product code is JSE – Culture Media, Multiple Biochemical Test, a Class I (low risk) device regulated under 21 CFR 866.2320.