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FDA 510(k)

PEFAKIT APC-R FACTOR V LEIDEN

K-Number: K042762 · 2004-12-22

ApplicantPentapharm , Ltd.
Decision Date2004-12-22
Product CodeGGW
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PEFAKIT APC-R FACTOR V LEIDEN is the device name listed in this FDA 510(k) record. The listed applicant is Pentapharm , Ltd.. It received FDA 510(k) clearance on 2004-12-22 under 510(k) number K042762. 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 PEFAKIT APC-R FACTOR V LEIDEN?

PEFAKIT APC-R FACTOR V LEIDEN is a medical device that received FDA 510(k) clearance on 2004-12-22. The listed applicant is Pentapharm , Ltd.. The 510(k) number is K042762.

When did PEFAKIT APC-R FACTOR V LEIDEN receive FDA 510(k) clearance?

PEFAKIT APC-R FACTOR V LEIDEN received FDA 510(k) clearance on 2004-12-22, under 510(k) number K042762.

Who is the listed applicant for PEFAKIT APC-R FACTOR V LEIDEN?

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

What is the FDA product code for PEFAKIT APC-R FACTOR V LEIDEN?

The FDA product code for PEFAKIT APC-R FACTOR V LEIDEN is GGW.

Related Clinical Trials

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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Other records listing Pentapharm , Ltd. 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.

K042760PEFAKIT APC-R FACTOR V LEIDEN CONTROLS

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.K033471PHOSPHOLIN ES AND CALCIUM CHLORIDER2 Diagnostics, Inc.K992456GRADILEIDEN V TESTGradipore , Ltd.

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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