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FDA 510(k)

LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA

K-Number: K083878 · 2010-06-25

ApplicantR2 Diagnostics, Inc.
Decision Date2010-06-25
Product CodeGIR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA 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 2010-06-25 under 510(k) number K083878. The device is classified under product code GIR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA?

LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA is a medical device that received FDA 510(k) clearance on 2010-06-25. The listed applicant is R2 Diagnostics, Inc.. The 510(k) number is K083878.

When did LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA receive FDA 510(k) clearance?

LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA received FDA 510(k) clearance on 2010-06-25, under 510(k) number K083878.

Who is the listed applicant for LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA?

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 LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA?

The FDA product code for LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA is GIR.

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Other records listing R2 Diagnostics, Inc. 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.

K102908NOFACT IXK102851NOFACT VIIIK090105LUPOTEK KCTK082631THROMBO TEK PSE, MODEL 90-480K062306PLASMACON N, PLASMACON L-1, PLASMACON L-2K050817T-TEK

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Related Devices (Code: GIR)

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.

K110031HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRMInstrumentation Laboratory COK061805STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRMDiagnostica Stago, Inc.K000527ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094Sigma Diagnostics, Inc.K000528ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119Sigma Diagnostics, Inc.K990580CRYOCHECK LA SURE, MODEL SUR25-10Precision BiologicK990579CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML)Precision Biologic

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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