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FDA 510(k)

CRYO CHECK FACTOR X DEFICIENT PLASMA

K-Number: K971227 · 1997-07-18

ApplicantPrecision Biologicals, Inc.
Decision Date1997-07-18
Product CodeGJT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CRYO CHECK FACTOR X DEFICIENT PLASMA is the device name listed in this FDA 510(k) record. The listed applicant is Precision Biologicals, Inc.. It received FDA 510(k) clearance on 1997-07-18 under 510(k) number K971227. 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 CRYO CHECK FACTOR X DEFICIENT PLASMA?

CRYO CHECK FACTOR X DEFICIENT PLASMA is a medical device that received FDA 510(k) clearance on 1997-07-18. The listed applicant is Precision Biologicals, Inc.. The 510(k) number is K971227.

When did CRYO CHECK FACTOR X DEFICIENT PLASMA receive FDA 510(k) clearance?

CRYO CHECK FACTOR X DEFICIENT PLASMA received FDA 510(k) clearance on 1997-07-18, under 510(k) number K971227.

Who is the listed applicant for CRYO CHECK FACTOR X DEFICIENT PLASMA?

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

What is the FDA product code for CRYO CHECK FACTOR X DEFICIENT PLASMA?

The FDA product code for CRYO CHECK FACTOR X DEFICIENT PLASMA is GJT.

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Other records listing Precision Biologicals, 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.

K982062CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10K981174CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML)K981173CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML)K971219CRYO CHECK INR VALIDATION SETK971222CRYO CHECK APC RESISTANT PLASMAK971223CRYO CHECK FACTOR V 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

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