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FDA 510(k)

LA POSITIVE CONTROL PLASMA

K-Number: K961370 · 1996-05-24

ApplicantMedical Diagnostic Technologies, Inc.
Decision Date1996-05-24
Product CodeGGC
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

LA POSITIVE CONTROL PLASMA is the device name listed in this FDA 510(k) record. The listed applicant is Medical Diagnostic Technologies, Inc.. It received FDA 510(k) clearance on 1996-05-24 under 510(k) number K961370. 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 LA POSITIVE CONTROL PLASMA?

LA POSITIVE CONTROL PLASMA is a medical device that received FDA 510(k) clearance on 1996-05-24. The listed applicant is Medical Diagnostic Technologies, Inc.. The 510(k) number is K961370.

When did LA POSITIVE CONTROL PLASMA receive FDA 510(k) clearance?

LA POSITIVE CONTROL PLASMA received FDA 510(k) clearance on 1996-05-24, under 510(k) number K961370.

Who is the listed applicant for LA POSITIVE CONTROL PLASMA?

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

What is the FDA product code for LA POSITIVE CONTROL PLASMA?

The FDA product code for LA POSITIVE CONTROL PLASMA is GGC.

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Other records listing Medical Diagnostic Technologies, 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.

K062229CTC WORKSTATION, MODEL 2200K972209SPECTROLYSE HEPARIN (ANTI-IIA)K963106CHROMOLIZE PAI-1 KITK960871SPECTROLYSE ANTITHROMBIN III (ANTI-XA)K962489CHROMOLIZE TPA ASSAY KITK960438TINTELIZE PAI-1 KIT

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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 →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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