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FDA 510(k)

CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML)

K-Number: K981173 · 1999-01-13

ApplicantPrecision Biologicals, Inc.
Decision Date1999-01-13
Product CodeGJT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML) 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 1999-01-13 under 510(k) number K981173. 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 XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML)?

CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML) is a medical device that received FDA 510(k) clearance on 1999-01-13. The listed applicant is Precision Biologicals, Inc.. The 510(k) number is K981173.

When did CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML) receive FDA 510(k) clearance?

CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML) received FDA 510(k) clearance on 1999-01-13, under 510(k) number K981173.

Who is the listed applicant for CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML)?

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 XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML)?

The FDA product code for CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML) is GJT.

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Official Source

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