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FDA 510(k)

LUMI-AGGREGOMETER

K-Number: K771198 · 1977-08-02

ApplicantChrono-Log Corp.
Decision Date1977-08-02
Product CodeJBY
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

LUMI-AGGREGOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Chrono-Log Corp.. It received FDA 510(k) clearance on 1977-08-02 under 510(k) number K771198. The device is classified under product code JBY. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUMI-AGGREGOMETER?

LUMI-AGGREGOMETER is a medical device that received FDA 510(k) clearance on 1977-08-02. The listed applicant is Chrono-Log Corp.. The 510(k) number is K771198.

When did LUMI-AGGREGOMETER receive FDA 510(k) clearance?

LUMI-AGGREGOMETER received FDA 510(k) clearance on 1977-08-02, under 510(k) number K771198.

Who is the listed applicant for LUMI-AGGREGOMETER?

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

What is the FDA product code for LUMI-AGGREGOMETER?

The FDA product code for LUMI-AGGREGOMETER is JBY.

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Other records listing Chrono-Log Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K161329Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channelK050265CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700K032951CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592AK962426CHRONO-LOG WHOLE BLOOD AGGREGOMETER (WBA) 591/592K945414RISTOCETIN COFACTOR ASSAY KITK940792AGGRO/LINK VW COFACTOR SOFTWARE

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Related Devices (Code: JBY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K912201PACKS-4 (TM) ANALYZERHelena Laboratories

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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