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FDA 510(k)

KIT, PLATELET AGGREGATION REAGENT (#390)

K-Number: K760198 · 1976-07-19

ApplicantChrono-Log Corp.
Decision Date1976-07-19
Product CodeGHR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

KIT, PLATELET AGGREGATION REAGENT (#390) 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 1976-07-19 under 510(k) number K760198. The device is classified under product code GHR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KIT, PLATELET AGGREGATION REAGENT (#390)?

KIT, PLATELET AGGREGATION REAGENT (#390) is a medical device that received FDA 510(k) clearance on 1976-07-19. The listed applicant is Chrono-Log Corp.. The 510(k) number is K760198.

When did KIT, PLATELET AGGREGATION REAGENT (#390) receive FDA 510(k) clearance?

KIT, PLATELET AGGREGATION REAGENT (#390) received FDA 510(k) clearance on 1976-07-19, under 510(k) number K760198.

Who is the listed applicant for KIT, PLATELET AGGREGATION REAGENT (#390)?

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 KIT, PLATELET AGGREGATION REAGENT (#390)?

The FDA product code for KIT, PLATELET AGGREGATION REAGENT (#390) is GHR.

Related Clinical Trials

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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: GHR)

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.

K061991PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACAHelena LaboratoriesK952252ADP REAGENT, MODIFIEDHelena LaboratoriesK922800PLATELET AGGREGATION REAGENTSChrono-Log Corp.K910680EPINEPHRINE REAGENT, CAT. NO. 5367Helena LaboratoriesK910800ADP REAGENTHelena LaboratoriesK910706COLLAGEN REAGENT CAT. NO. 5368Helena 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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