Microgenics Cyclosporine Control Kit
FDA 510(k) K032842 · Microgenics Corp.
510(k) numberK032842
Submission
- Device name
- Microgenics Cyclosporine Control Kit
- Applicant
- Microgenics Corp.
Fremont Blvd., CA, US - Received
- September 11, 2003
- Decision date
- October 17, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LAS – Drug Specific Control Materials
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3280
- Specialty
- Clinical Toxicology
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Questions and answers
When was Microgenics Cyclosporine Control Kit cleared by the FDA?
Microgenics Cyclosporine Control Kit (K032842) received a 510(k) decision of Substantially Equivalent on October 17, 2003, 36 days after the submission was received.
What is the product code of K032842?
The FDA product code is LAS – Drug Specific Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.