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FDA 510(k)

COAGULATION REFERENCE PLASMA, ABNORMAL

K-Number: K904073 · 1990-10-22

ApplicantMedi-Tech, Inc.
Decision Date1990-10-22
Product CodeGGC
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COAGULATION REFERENCE PLASMA, ABNORMAL is the device name listed in this FDA 510(k) record. The listed applicant is Medi-Tech, Inc.. It received FDA 510(k) clearance on 1990-10-22 under 510(k) number K904073. The device is classified under product code GGC. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COAGULATION REFERENCE PLASMA, ABNORMAL?

COAGULATION REFERENCE PLASMA, ABNORMAL is a medical device that received FDA 510(k) clearance on 1990-10-22. The listed applicant is Medi-Tech, Inc.. The 510(k) number is K904073.

When did COAGULATION REFERENCE PLASMA, ABNORMAL receive FDA 510(k) clearance?

COAGULATION REFERENCE PLASMA, ABNORMAL received FDA 510(k) clearance on 1990-10-22, under 510(k) number K904073.

Who is the listed applicant for COAGULATION REFERENCE PLASMA, ABNORMAL?

The FDA 510(k) record lists Medi-Tech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COAGULATION REFERENCE PLASMA, ABNORMAL?

The FDA product code for COAGULATION REFERENCE PLASMA, ABNORMAL is GGC.

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K954457MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETERK952345MEDI-TECH PLATFORM GUIDE CATHETERK952056IMMUNOASSAY DRUGS OF ABUSE CONTROLSK945289DOA - IMMUNOASSAY CUT-OFF CALIBRATORK942551THERAPEUTIC DRUG MONITORING CONTROL, ASSAYEDK943290BILIRUBIN PLUS/PEDIATRIC CONTROLS

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Related Devices (Code: GGC)

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.

K102552HEMOSIL LA POSITIVE CONTROLInstrumentation Laboratory COK100103SPECIALTY ASSAYED CONTROL-2Helena LaboratoriesK062306PLASMACON N, PLASMACON L-1, PLASMACON L-2R2 Diagnostics, Inc.K061803STA - CONTROL LA 1+2Diagnostica Stago, Inc.K032804CRYOCHECK WEAK LUPUS POSITIVE CONTROLPrecision BiologicK023312CONTROL PLASMA PDade Behring, Inc.

Official Source

View on FDA Database →

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