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FDA 510(k)

COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S

K-Number: K963111 · 1996-12-23

ApplicantChromogenix AB
Decision Date1996-12-23
Product CodeGGW
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S is the device name listed in this FDA 510(k) record. The listed applicant is Chromogenix AB. It received FDA 510(k) clearance on 1996-12-23 under 510(k) number K963111. 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 COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S?

COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S is a medical device that received FDA 510(k) clearance on 1996-12-23. The listed applicant is Chromogenix AB. The 510(k) number is K963111.

When did COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S receive FDA 510(k) clearance?

COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S received FDA 510(k) clearance on 1996-12-23, under 510(k) number K963111.

Who is the listed applicant for COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S?

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

What is the FDA product code for COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S?

The FDA product code for COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S 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 Chromogenix AB 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.

K952515COACUTE ANTITHROMBIN R CHROMOGENIC ASSAYK952514COACUTE HEPARINK922201COAMATE PROTEIN C CHROMOGENIC ASSAY

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

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

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