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FDA 510(k)

CRYO CHECK NORMAL HUMAN REFERENCE PLASMA

K-Number: K952622 · 1995-10-30

ApplicantPrecision Biologicals, Inc.
Decision Date1995-10-30
Product CodeGGN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CRYO CHECK NORMAL HUMAN REFERENCE 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 1995-10-30 under 510(k) number K952622. The device is classified under product code GGN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRYO CHECK NORMAL HUMAN REFERENCE PLASMA?

CRYO CHECK NORMAL HUMAN REFERENCE PLASMA is a medical device that received FDA 510(k) clearance on 1995-10-30. The listed applicant is Precision Biologicals, Inc.. The 510(k) number is K952622.

When did CRYO CHECK NORMAL HUMAN REFERENCE PLASMA receive FDA 510(k) clearance?

CRYO CHECK NORMAL HUMAN REFERENCE PLASMA received FDA 510(k) clearance on 1995-10-30, under 510(k) number K952622.

Who is the listed applicant for CRYO CHECK NORMAL HUMAN REFERENCE 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 NORMAL HUMAN REFERENCE PLASMA?

The FDA product code for CRYO CHECK NORMAL HUMAN REFERENCE PLASMA is GGN.

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Other records listing Precision Biologicals, Inc. as applicant

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

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Related Devices (Code: GGN)

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K170864VALIDATE D-Dimer Calibration Verification / Linearity Test KitMaine Standards Company, LLCK163498VALIDATE Heparin Calibration Verification/Linearity Test KitMaine Standards Company, LLCK161316George King Coumadin PlasmaGeorge King Bio-Medical, Inc.K162705VALIDATE® D-Dimer Calibration Verification/ Linearity Test KitMaine Standards Company, LLCK152961VALIDATE D-Dimer Calibration Verification/Linearity Test KitMaine Standards Company, LLCK150144VisuCon-F Low Fibrinogen Control PlasmaAffinity Biologicals, 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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