FDA 510(k)

LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC

K-Number: K072721 · 2007-12-11

Decision Date2007-12-11

Product CodeDIF

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad, Diagnostics Grp.. It received FDA 510(k) clearance on 2007-12-11 under 510(k) number K072721. The device is classified under product code DIF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC?

LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC is a medical device that received FDA 510(k) clearance on 2007-12-11. The listed applicant is Bio-Rad, Diagnostics Grp.. The 510(k) number is K072721.

When did LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC receive FDA 510(k) clearance?

LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC received FDA 510(k) clearance on 2007-12-11, under 510(k) number K072721.

Who is the listed applicant for LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC?

The FDA 510(k) record lists Bio-Rad, Diagnostics Grp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC?

The FDA product code for LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC is DIF.

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Other records listing Bio-Rad, Diagnostics Grp. as applicant

K121794LIQUICHEK URINE CHEMISTRY CONTROL K100727LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED MULTIQUAL 3, LIQUID ASSAYED MULTIQUAL MINIPAK K072835LIQUICHEK MICROALBUMIN CONTROL LEVEL 1, LEVEL 2, CONTROL MINIPAK K071319I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02 K070848LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X

Related Devices (Code: DIF)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.