Carbohydrate Fermentation Media
FDA 510(k) K790617 · Anaerobe Systems
510(k) numberK790617
Submission
- Device name
- Carbohydrate Fermentation Media
- Applicant
- Anaerobe Systems
Mchenry, IL, US - Received
- March 29, 1979
- Decision date
- April 23, 1979
- 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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Questions and answers
When was Carbohydrate Fermentation Media cleared by the FDA?
Carbohydrate Fermentation Media (K790617) received a 510(k) decision of Substantially Equivalent on April 23, 1979, 25 days after the submission was received.
What is the product code of K790617?
The FDA product code is JSE – Culture Media, Multiple Biochemical Test, a Class I (low risk) device regulated under 21 CFR 866.2320.