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FDA 510(k)

ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119

K-Number: K000528 · 2000-04-07

ApplicantSigma Diagnostics, Inc.
Decision Date2000-04-07
Product CodeGIR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119 is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Diagnostics, Inc.. It received FDA 510(k) clearance on 2000-04-07 under 510(k) number K000528. 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 ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119?

ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119 is a medical device that received FDA 510(k) clearance on 2000-04-07. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K000528.

When did ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119 receive FDA 510(k) clearance?

ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119 received FDA 510(k) clearance on 2000-04-07, under 510(k) number K000528.

Who is the listed applicant for ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119?

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

What is the FDA product code for ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119?

The FDA product code for ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119 is GIR.

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Other records listing Sigma 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.

K021162AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHEDK020109SIGMA DIAGNOSTICS ACCUCLOT LA CONTROLK013549SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971K013544SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096K013545SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221K012410INFINITY HBA KIT, MODELS 537-A, 537-B

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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 COK083878LUPOTEK 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.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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