Macconkey Agar W/Tween 80 & Ampicil
FDA 510(k) K840190 · Remel Co.
510(k) numberK840190
Submission
- Device name
- Macconkey Agar W/Tween 80 & Ampicil
- Applicant
- Remel Co.
Mchenry, IL, US - Received
- January 18, 1984
- Decision date
- February 17, 1984
- 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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Questions and answers
When was Macconkey Agar W/Tween 80 & Ampicil cleared by the FDA?
Macconkey Agar W/Tween 80 & Ampicil (K840190) received a 510(k) decision of Substantially Equivalent on February 17, 1984, 30 days after the submission was received.
What is the product code of K840190?
The FDA product code is JSI – Culture Media, Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.