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FDA 510(k)

CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10

K-Number: K982062 · 1999-01-13

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

Device Summary

CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10 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 K982062. The device is classified under product code GGW. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10?

CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10 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 K982062.

When did CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10 receive FDA 510(k) clearance?

CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10 received FDA 510(k) clearance on 1999-01-13, under 510(k) number K982062.

Who is the listed applicant for CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10?

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 PNP PLATELET LYSATE, MODEL PNP-10?

The FDA product code for CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10 is GGW.

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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.

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Related Devices (Code: GGW)

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.

K260551HemosIL Factor V Leiden (APC Resistance V)Instrumentation Laboratory (IL) Co.K090105LUPOTEK KCTR2 Diagnostics, Inc.K083729HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHENAniara Diagnostica, LLCK060284CRYOCHECK CLOT APCRPrecision Biologic, Inc.K042762PEFAKIT APC-R FACTOR V LEIDENPentapharm , Ltd.K033471PHOSPHOLIN ES AND CALCIUM CHLORIDER2 Diagnostics, 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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