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FDA 510(k)

ACCUCLOT CONTROL I, MODEL A4089

K-Number: K003328 · 2001-03-01

ApplicantSigma Diagnostics, Inc.
Decision Date2001-03-01
Product CodeGIZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ACCUCLOT CONTROL I, MODEL A4089 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 2001-03-01 under 510(k) number K003328. The device is classified under product code GIZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUCLOT CONTROL I, MODEL A4089?

ACCUCLOT CONTROL I, MODEL A4089 is a medical device that received FDA 510(k) clearance on 2001-03-01. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K003328.

When did ACCUCLOT CONTROL I, MODEL A4089 receive FDA 510(k) clearance?

ACCUCLOT CONTROL I, MODEL A4089 received FDA 510(k) clearance on 2001-03-01, under 510(k) number K003328.

Who is the listed applicant for ACCUCLOT CONTROL I, MODEL A4089?

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 CONTROL I, MODEL A4089?

The FDA product code for ACCUCLOT CONTROL I, MODEL A4089 is GIZ.

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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: GIZ)

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.

K060968STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOWWortham Laboratories, Inc.K042941DADE BEHRING HEPARIN CALIBRATOR AND CONTROLSDade Behring, Inc.K023309CONTROL PLASMA NDade Behring, Inc.K013708REFERENCE CHECK, CATALOG NUMBER-RCN-10Precision BiologicK001256CONTROL PLASMA NDade Behring, Inc.K984129COAGULATION CONTROL LEVEL 1 (NORMAL)Pacific Hemostasis

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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