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FDA 510(k)

LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV

K-Number: K091303 · 2010-08-02

ApplicantBio-Rad Laboratories
Decision Date2010-08-02
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad Laboratories. It received FDA 510(k) clearance on 2010-08-02 under 510(k) number K091303. The device is classified under product code JPK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV?

LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV is a medical device that received FDA 510(k) clearance on 2010-08-02. The listed applicant is Bio-Rad Laboratories. The 510(k) number is K091303.

When did LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV receive FDA 510(k) clearance?

LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV received FDA 510(k) clearance on 2010-08-02, under 510(k) number K091303.

Who is the listed applicant for LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV?

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

What is the FDA product code for LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV?

The FDA product code for LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV is JPK.

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Related Devices (Code: JPK)

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Official Source

View on FDA Database →

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

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