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FDA 510(k)

HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM

K-Number: K110031 · 2011-08-24

ApplicantInstrumentation Laboratory CO
Decision Date2011-08-24
Product CodeGIR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 2011-08-24 under 510(k) number K110031. 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 HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM?

HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM is a medical device that received FDA 510(k) clearance on 2011-08-24. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K110031.

When did HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM receive FDA 510(k) clearance?

HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM received FDA 510(k) clearance on 2011-08-24, under 510(k) number K110031.

Who is the listed applicant for HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM?

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

What is the FDA product code for HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM?

The FDA product code for HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM is GIR.

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Other records listing Instrumentation Laboratory CO as applicant

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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.

K083878LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LAR2 Diagnostics, Inc.K061805STA - 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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