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FDA 510(k)

ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER

K-Number: K962664 · 1996-09-10

ApplicantMedical Laboratory Automation Systems, Inc.
Decision Date1996-09-10
Product CodeGKP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Medical Laboratory Automation Systems, Inc.. It received FDA 510(k) clearance on 1996-09-10 under 510(k) number K962664. 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 ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER?

ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER is a medical device that received FDA 510(k) clearance on 1996-09-10. The listed applicant is Medical Laboratory Automation Systems, Inc.. The 510(k) number is K962664.

When did ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER receive FDA 510(k) clearance?

ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER received FDA 510(k) clearance on 1996-09-10, under 510(k) number K962664.

Who is the listed applicant for ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER?

The FDA 510(k) record lists Medical Laboratory Automation Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER?

The FDA product code for ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER is GKP.

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Other records listing Medical Laboratory Automation Systems, Inc. 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.

K944227ELECTRA 1400C AUTOMATIC COAGULATION ANALYZERK931206ELECTRA 1600C AUTOMATIC COAGULATION TIMERK923220THROMBIN CLOT TIME TEST PROCEDUREK903638GASTRO-INTESTINAL ACCU-CULSHURE TMK903405CHLAMYDIA ACCU-CULSHURE TMK903406VIRAL ACCU-CULSHURE TM

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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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