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FDA 510(k)

COAGULATION REFERENCE PLASMA, NORMAL

K-Number: K905203 · 1990-12-28

ApplicantMedical Diagnostic Technologies, Inc.
Decision Date1990-12-28
Product CodeGIZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COAGULATION REFERENCE PLASMA, NORMAL 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 1990-12-28 under 510(k) number K905203. The device is classified under product code GIZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COAGULATION REFERENCE PLASMA, NORMAL?

COAGULATION REFERENCE PLASMA, NORMAL is a medical device that received FDA 510(k) clearance on 1990-12-28. The listed applicant is Medical Diagnostic Technologies, Inc.. The 510(k) number is K905203.

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

COAGULATION REFERENCE PLASMA, NORMAL received FDA 510(k) clearance on 1990-12-28, under 510(k) number K905203.

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

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 COAGULATION REFERENCE PLASMA, NORMAL?

The FDA product code for COAGULATION REFERENCE PLASMA, NORMAL is GIZ.

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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: GIZ)

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.

K060968STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOWWortham Laboratories, Inc.K042941DADE BEHRING HEPARIN CALIBRATOR AND CONTROLSDade Behring, Inc.K023309CONTROL PLASMA NDade Behring, Inc.K013708REFERENCE CHECK, CATALOG NUMBER-RCN-10Precision BiologicK003328ACCUCLOT CONTROL I, MODEL A4089Sigma Diagnostics, Inc.K001256CONTROL PLASMA NDade 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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