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FDA 510(k)

COATEST(R) APC(TM) RESISTANCE

K-Number: K945940 · 1995-08-07

ApplicantAxis-Shield Doc AS
Decision Date1995-08-07
Product CodeGGW
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COATEST(R) APC(TM) RESISTANCE is the device name listed in this FDA 510(k) record. The listed applicant is Axis-Shield Doc AS. It received FDA 510(k) clearance on 1995-08-07 under 510(k) number K945940. 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(R) APC(TM) RESISTANCE?

COATEST(R) APC(TM) RESISTANCE is a medical device that received FDA 510(k) clearance on 1995-08-07. The listed applicant is Axis-Shield Doc AS. The 510(k) number is K945940.

When did COATEST(R) APC(TM) RESISTANCE receive FDA 510(k) clearance?

COATEST(R) APC(TM) RESISTANCE received FDA 510(k) clearance on 1995-08-07, under 510(k) number K945940.

Who is the listed applicant for COATEST(R) APC(TM) RESISTANCE?

The FDA 510(k) record lists Axis-Shield Doc AS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COATEST(R) APC(TM) RESISTANCE?

The FDA product code for COATEST(R) APC(TM) RESISTANCE is GGW.

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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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