Lyphochek Whole Blood Immunosuppressant Control , Abbott Immunosuppressant MCC
FDA 510(k) K072721 · Bio-Rad, Diagnostics Grp.
510(k) numberK072721
Submission
- Device name
- Lyphochek Whole Blood Immunosuppressant Control , Abbott Immunosuppressant MCC
- Applicant
- Bio-Rad, Diagnostics Grp.
Irvine, CA, US - Received
- September 26, 2007
- Decision date
- December 11, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DIF – Drug Mixture 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 Lyphochek Whole Blood Immunosuppressant Control , Abbott Immunosuppressant MCC cleared by the FDA?
Lyphochek Whole Blood Immunosuppressant Control , Abbott Immunosuppressant MCC (K072721) received a 510(k) decision of Substantially Equivalent on December 11, 2007, 76 days after the submission was received.
What is the product code of K072721?
The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.