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FDA 510(k)

FACTOR DEFICIENT PLASMAS - FACTOR XI (11)

K-Number: K972286 · 1997-07-14

ApplicantUniversal Reagents, Inc.
Decision Date1997-07-14
Product CodeGJT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FACTOR DEFICIENT PLASMAS - FACTOR XI (11) 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 1997-07-14 under 510(k) number K972286. 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 FACTOR DEFICIENT PLASMAS - FACTOR XI (11)?

FACTOR DEFICIENT PLASMAS - FACTOR XI (11) is a medical device that received FDA 510(k) clearance on 1997-07-14. The listed applicant is Universal Reagents, Inc.. The 510(k) number is K972286.

When did FACTOR DEFICIENT PLASMAS - FACTOR XI (11) receive FDA 510(k) clearance?

FACTOR DEFICIENT PLASMAS - FACTOR XI (11) received FDA 510(k) clearance on 1997-07-14, under 510(k) number K972286.

Who is the listed applicant for FACTOR DEFICIENT PLASMAS - FACTOR XI (11)?

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 FACTOR DEFICIENT PLASMAS - FACTOR XI (11)?

The FDA product code for FACTOR DEFICIENT PLASMAS - FACTOR XI (11) 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)K970593UNIVERSAL REAGENT FACTOR VIII DEFICIENT PLASMAK970607UNIVERSAL REAGENT FACTOR VII 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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