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FDA 510(k)

PLATELET AGGREGOMETERS

K-Number: K820422 · 1982-03-16

ApplicantChrono-Log Corp.
Decision Date1982-03-16
Product CodeGHR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PLATELET AGGREGOMETERS 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 1982-03-16 under 510(k) number K820422. 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 PLATELET AGGREGOMETERS?

PLATELET AGGREGOMETERS is a medical device that received FDA 510(k) clearance on 1982-03-16. The listed applicant is Chrono-Log Corp.. The 510(k) number is K820422.

When did PLATELET AGGREGOMETERS receive FDA 510(k) clearance?

PLATELET AGGREGOMETERS received FDA 510(k) clearance on 1982-03-16, under 510(k) number K820422.

Who is the listed applicant for PLATELET AGGREGOMETERS?

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 PLATELET AGGREGOMETERS?

The FDA product code for PLATELET AGGREGOMETERS is GHR.

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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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