Rpmi 1640 Agar W/Mops and 2% Glucose
FDA 510(k) K072827 · Remel, Inc.
510(k) numberK072827
Submission
- Device name
- Rpmi 1640 Agar W/Mops and 2% Glucose
- Applicant
- Remel, Inc.
Lenexa, KS, US - Received
- October 3, 2007
- Decision date
- November 26, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MJE – Culture Media, Antifungal, Susceptibility Test
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1700
- Specialty
- Microbiology
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Questions and answers
When was Rpmi 1640 Agar W/Mops and 2% Glucose cleared by the FDA?
Rpmi 1640 Agar W/Mops and 2% Glucose (K072827) received a 510(k) decision of Substantially Equivalent on November 26, 2007, 54 days after the submission was received.
What is the product code of K072827?
The FDA product code is MJE – Culture Media, Antifungal, Susceptibility Test, a Class II (moderate risk) device regulated under 21 CFR 866.1700.