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FDA 510(k)

ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770

K-Number: K020914 · 2002-05-23

ApplicantHelena Laboratories
Decision Date2002-05-23
Product CodeJBP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770 is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 2002-05-23 under 510(k) number K020914. The device is classified under product code JBP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770?

ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770 is a medical device that received FDA 510(k) clearance on 2002-05-23. The listed applicant is Helena Laboratories. The 510(k) number is K020914.

When did ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770 receive FDA 510(k) clearance?

ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770 received FDA 510(k) clearance on 2002-05-23, under 510(k) number K020914.

Who is the listed applicant for ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770?

The FDA 510(k) record lists Helena Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770?

The FDA product code for ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770 is JBP.

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Other records listing Helena Laboratories 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.

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Related Devices (Code: JBP)

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.

K223635Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot ViewerSienco, Inc.K062604RAPIDTEG TEG-ACT TESTHaemoscope Corp.K032952AIACT KITSienco, Inc.K023582I-STAT KAOLIN ACT TESTI-Stat CorporationK013078ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752Helena LaboratoriesK002528SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTIONSienco, Inc.

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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