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FDA 510(k)

RISTOCETIN COFACTOR ASSAY KIT

K-Number: K945414 · 1995-01-11

ApplicantChrono-Log Corp.
Decision Date1995-01-11
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

RISTOCETIN COFACTOR ASSAY KIT 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 1995-01-11 under 510(k) number K945414. The device is classified under product code GGP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RISTOCETIN COFACTOR ASSAY KIT?

RISTOCETIN COFACTOR ASSAY KIT is a medical device that received FDA 510(k) clearance on 1995-01-11. The listed applicant is Chrono-Log Corp.. The 510(k) number is K945414.

When did RISTOCETIN COFACTOR ASSAY KIT receive FDA 510(k) clearance?

RISTOCETIN COFACTOR ASSAY KIT received FDA 510(k) clearance on 1995-01-11, under 510(k) number K945414.

Who is the listed applicant for RISTOCETIN COFACTOR ASSAY KIT?

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 RISTOCETIN COFACTOR ASSAY KIT?

The FDA product code for RISTOCETIN COFACTOR ASSAY KIT is GGP.

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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) 591/592K940792AGGRO/LINK VW COFACTOR SOFTWAREK932566AGGRO/LINK CONTROL SOFTWARE

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Related Devices (Code: GGP)

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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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