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FDA 510(k)

UNIVERSAL REAGENT FACTOR VII DEFICIENT PLASMA

K-Number: K970607 · 1997-04-25

ApplicantUniversal Reagents, Inc.
Decision Date1997-04-25
Product CodeGJT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

UNIVERSAL REAGENT FACTOR VII DEFICIENT PLASMA is the device name listed in this FDA 510(k) record. The listed applicant is Universal Reagents, Inc.. It received FDA 510(k) clearance on 1997-04-25 under 510(k) number K970607. The device is classified under product code GJT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIVERSAL REAGENT FACTOR VII DEFICIENT PLASMA?

UNIVERSAL REAGENT FACTOR VII DEFICIENT PLASMA is a medical device that received FDA 510(k) clearance on 1997-04-25. The listed applicant is Universal Reagents, Inc.. The 510(k) number is K970607.

When did UNIVERSAL REAGENT FACTOR VII DEFICIENT PLASMA receive FDA 510(k) clearance?

UNIVERSAL REAGENT FACTOR VII DEFICIENT PLASMA received FDA 510(k) clearance on 1997-04-25, under 510(k) number K970607.

Who is the listed applicant for UNIVERSAL REAGENT FACTOR VII DEFICIENT PLASMA?

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

What is the FDA product code for UNIVERSAL REAGENT FACTOR VII DEFICIENT PLASMA?

The FDA product code for UNIVERSAL REAGENT FACTOR VII DEFICIENT PLASMA is GJT.

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Other records listing Universal Reagents, 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.

K973143UNIVERSAL REAGENT FACTOR XII (TWELVE) DEFICIENT PLASMAK972288FACTOR DEFICIENT PLASMAS - FACTOR IX (9)K972286FACTOR DEFICIENT PLASMAS - FACTOR XI (11)K970593UNIVERSAL REAGENT FACTOR VIII DEFICIENT PLASMAK964270UNIVERSAL REAGENT FACTOR V DEFICIENT PLASMAK964459UNIVERSAL REAGENT FACTOR X DEFICIENT PLASMA

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Related Devices (Code: GJT)

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.

K222831CRYOcheck Factor VIII Deficient Plasma with VWFPrecision Biologic, Inc.K180486HemosIL Factor XII Deficient PlasmaInstrumentation Laboratory COK102851NOFACT VIIIR2 Diagnostics, Inc.K102908NOFACT IXR2 Diagnostics, Inc.K110237HEMOSIL FACTOR VIII DEFICIENT PLASMAInstrumentation Laboratory COK050661HEMOSIL FACTOR II DEFICIENT PLASMAInstrumentation 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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