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FDA 510(k)

MICROSAMPLE COAGULATION ANALYZER

K-Number: K943153 · 1995-03-24

ApplicantBio/Data Corp.
Decision Date1995-03-24
Product CodeGKP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MICROSAMPLE COAGULATION ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Bio/Data Corp.. It received FDA 510(k) clearance on 1995-03-24 under 510(k) number K943153. The device is classified under product code GKP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROSAMPLE COAGULATION ANALYZER?

MICROSAMPLE COAGULATION ANALYZER is a medical device that received FDA 510(k) clearance on 1995-03-24. The listed applicant is Bio/Data Corp.. The 510(k) number is K943153.

When did MICROSAMPLE COAGULATION ANALYZER receive FDA 510(k) clearance?

MICROSAMPLE COAGULATION ANALYZER received FDA 510(k) clearance on 1995-03-24, under 510(k) number K943153.

Who is the listed applicant for MICROSAMPLE COAGULATION ANALYZER?

The FDA 510(k) record lists Bio/Data Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROSAMPLE COAGULATION ANALYZER?

The FDA product code for MICROSAMPLE COAGULATION ANALYZER is GKP.

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Other records listing Bio/Data 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.

K001891MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-CK893650PLATELET AGGREGATION PROFILER MODEL PAP-4CK881150KINETIC FIBRINOGEN ASSAYK873382PLATELET EXTRACT REAGENTK860751VON WILLEBRAND FAC. DEFIC. ABNORMAL CONTROL PLASMAK860342MICROSAMPLE COAGULATION ANALYSER, MODEL 110WP

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Related Devices (Code: GKP)

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.

K242127ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)Instrumentation Laboratory (IL) Co.K231031ACL TOP Family 70 SeriesInstrumentation Laboratory CompanyK160276ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)Instrumentation Laboratory COK091980ACL TOP 700 LASInstrumentation Laboratory COK073377ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)Instrumentation Laboratory COK063679ACL TOPInstrumentation Laboratory 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.

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