FDA 510(k)

CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML)

K-Number: K990296 · 1999-03-18

Decision Date1999-03-18

Product CodeGJT

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML) is the device name listed in this FDA 510(k) record. The listed applicant is Precision Biologic. It received FDA 510(k) clearance on 1999-03-18 under 510(k) number K990296. 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 CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML)?

CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML) is a medical device that received FDA 510(k) clearance on 1999-03-18. The listed applicant is Precision Biologic. The 510(k) number is K990296.

When did CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML) receive FDA 510(k) clearance?

CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML) received FDA 510(k) clearance on 1999-03-18, under 510(k) number K990296.

Who is the listed applicant for CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML)?

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

What is the FDA product code for CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML)?

The FDA product code for CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML) is GJT.

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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.