Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PLATELET AGGREGATION REAGENT

K-Number: K850592 · 1985-05-13

ApplicantChrono-Log Corp.
Decision Date1985-05-13
Product CodeJBX
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PLATELET AGGREGATION REAGENT 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 1985-05-13 under 510(k) number K850592. The device is classified under product code JBX. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLATELET AGGREGATION REAGENT?

PLATELET AGGREGATION REAGENT is a medical device that received FDA 510(k) clearance on 1985-05-13. The listed applicant is Chrono-Log Corp.. The 510(k) number is K850592.

When did PLATELET AGGREGATION REAGENT receive FDA 510(k) clearance?

PLATELET AGGREGATION REAGENT received FDA 510(k) clearance on 1985-05-13, under 510(k) number K850592.

Who is the listed applicant for PLATELET AGGREGATION REAGENT?

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 AGGREGATION REAGENT?

The FDA product code for PLATELET AGGREGATION REAGENT is JBX.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 16 devices →

Related Devices (Code: JBX)

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.

K932566AGGRO/LINK CONTROL SOFTWAREChrono-Log Corp.K912774ARACHIDONIC ACIDHelena LaboratoriesK881829PAT PLATELET AGGREGATION TESTStreck Laboratories, Inc.K862775ASSERACHROM B-TG KITAmerican Bioproducts Co.K851025AGGRO/LINK COMPUTER INTERFACEChrono-Log Corp.K832929RISTOCETIN PLATELET AGGREGA-REAGENT TESTSigma Chemical Co.

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.

↑