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FDA 510(k)

PHOSPHOLIN ES AND CALCIUM CHLORIDE

K-Number: K033471 · 2004-02-04

ApplicantR2 Diagnostics, Inc.
Decision Date2004-02-04
Product CodeGGW
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PHOSPHOLIN ES AND CALCIUM CHLORIDE is the device name listed in this FDA 510(k) record. The listed applicant is R2 Diagnostics, Inc.. It received FDA 510(k) clearance on 2004-02-04 under 510(k) number K033471. 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 PHOSPHOLIN ES AND CALCIUM CHLORIDE?

PHOSPHOLIN ES AND CALCIUM CHLORIDE is a medical device that received FDA 510(k) clearance on 2004-02-04. The listed applicant is R2 Diagnostics, Inc.. The 510(k) number is K033471.

When did PHOSPHOLIN ES AND CALCIUM CHLORIDE receive FDA 510(k) clearance?

PHOSPHOLIN ES AND CALCIUM CHLORIDE received FDA 510(k) clearance on 2004-02-04, under 510(k) number K033471.

Who is the listed applicant for PHOSPHOLIN ES AND CALCIUM CHLORIDE?

The FDA 510(k) record lists R2 Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHOSPHOLIN ES AND CALCIUM CHLORIDE?

The FDA product code for PHOSPHOLIN ES AND CALCIUM CHLORIDE is GGW.

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Related Devices (Code: GGW)

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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.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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