FDA 510(k)

POSITIVE LUPUS ANTICOAGULANT PLASMA

K-Number: K945856 · 1995-10-05

Decision Date1995-10-05

Product CodeGGC

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

POSITIVE LUPUS ANTICOAGULANT PLASMA is the device name listed in this FDA 510(k) record. The listed applicant is George King Bio-Medical, Inc.. It received FDA 510(k) clearance on 1995-10-05 under 510(k) number K945856. 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 POSITIVE LUPUS ANTICOAGULANT PLASMA?

POSITIVE LUPUS ANTICOAGULANT PLASMA is a medical device that received FDA 510(k) clearance on 1995-10-05. The listed applicant is George King Bio-Medical, Inc.. The 510(k) number is K945856.

When did POSITIVE LUPUS ANTICOAGULANT PLASMA receive FDA 510(k) clearance?

POSITIVE LUPUS ANTICOAGULANT PLASMA received FDA 510(k) clearance on 1995-10-05, under 510(k) number K945856.

Who is the listed applicant for POSITIVE LUPUS ANTICOAGULANT PLASMA?

The FDA 510(k) record lists George King Bio-Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POSITIVE LUPUS ANTICOAGULANT PLASMA?

The FDA product code for POSITIVE LUPUS ANTICOAGULANT PLASMA is GGC.

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Other records listing George King Bio-Medical, Inc. as applicant

K161316George King Coumadin Plasma K945855A-FACT, ABNORMAL FACTOR ASSAY CONTROL K945854B-FACT, BORDERLINE FACTOR ASSAY CONTROL K945857PROTEIN C DEFICIENT PLASMA

Related Devices (Code: GGC)

K102552HEMOSIL LA POSITIVE CONTROLInstrumentation Laboratory CO K100103SPECIALTY ASSAYED CONTROL-2Helena Laboratories K062306PLASMACON N, PLASMACON L-1, PLASMACON L-2R2 Diagnostics, Inc.K061803STA - CONTROL LA 1+2Diagnostica Stago, Inc.K032804CRYOCHECK WEAK LUPUS POSITIVE CONTROLPrecision Biologic K023312CONTROL PLASMA PDade Behring, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.