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FDA 510(k)

CRYO CHECK LUPUS PLASMA

K-Number: K952623 · 1995-11-06

ApplicantPrecision Biologicals, Inc.
Decision Date1995-11-06
Product CodeGGC
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CRYO CHECK LUPUS 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 1995-11-06 under 510(k) number K952623. The device is classified under product code GGC. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRYO CHECK LUPUS PLASMA?

CRYO CHECK LUPUS PLASMA is a medical device that received FDA 510(k) clearance on 1995-11-06. The listed applicant is Precision Biologicals, Inc.. The 510(k) number is K952623.

When did CRYO CHECK LUPUS PLASMA receive FDA 510(k) clearance?

CRYO CHECK LUPUS PLASMA received FDA 510(k) clearance on 1995-11-06, under 510(k) number K952623.

Who is the listed applicant for CRYO CHECK LUPUS 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 LUPUS PLASMA?

The FDA product code for CRYO CHECK LUPUS PLASMA is GGC.

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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.

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: GGC)

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.

K102552HEMOSIL LA POSITIVE CONTROLInstrumentation Laboratory COK100103SPECIALTY ASSAYED CONTROL-2Helena LaboratoriesK062306PLASMACON N, PLASMACON L-1, PLASMACON L-2R2 Diagnostics, Inc.K061803STA - CONTROL LA 1+2Diagnostica Stago, Inc.K032804CRYOCHECK WEAK LUPUS POSITIVE CONTROLPrecision BiologicK023312CONTROL PLASMA PDade 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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