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FDA 510(k)

LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789

K-Number: K990858 · 1999-04-21

ApplicantBio-Rad
Decision Date1999-04-21
Product CodeGGN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1999-04-21 under 510(k) number K990858. The device is classified under product code GGN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789?

LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789 is a medical device that received FDA 510(k) clearance on 1999-04-21. The listed applicant is Bio-Rad. The 510(k) number is K990858.

When did LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789 receive FDA 510(k) clearance?

LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789 received FDA 510(k) clearance on 1999-04-21, under 510(k) number K990858.

Who is the listed applicant for LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789?

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

What is the FDA product code for LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789?

The FDA product code for LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789 is GGN.

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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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