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FDA 510(k)

TAS ANALYZER

K-Number: K933092 · 1993-11-15

ApplicantCardiovascular Diagnostic Services
Decision Date1993-11-15
Product CodeGKP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

TAS ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Cardiovascular Diagnostic Services. It received FDA 510(k) clearance on 1993-11-15 under 510(k) number K933092. 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 TAS ANALYZER?

TAS ANALYZER is a medical device that received FDA 510(k) clearance on 1993-11-15. The listed applicant is Cardiovascular Diagnostic Services. The 510(k) number is K933092.

When did TAS ANALYZER receive FDA 510(k) clearance?

TAS ANALYZER received FDA 510(k) clearance on 1993-11-15, under 510(k) number K933092.

Who is the listed applicant for TAS ANALYZER?

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

What is the FDA product code for TAS ANALYZER?

The FDA product code for TAS ANALYZER is GKP.

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.

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Other records listing Cardiovascular Diagnostic Services 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.

K955843TAS PTONEK904325COAG-1 PT-NC TEST CARDK903019MODIFIED COAG-1 PT TEST CARDK891015COAG-1 APTT TEST CARDK882444COAG-I ANALYZER, ALPHA MODELK882456COAG-I PT TEST CARD

View all 8 devices →

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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