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FDA 510(k)

SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III

K-Number: K972144 · 1997-07-25

ApplicantSigma Diagnostics, Inc.
Decision Date1997-07-25
Product CodeJBQ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III 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 1997-07-25 under 510(k) number K972144. The device is classified under product code JBQ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III?

SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III is a medical device that received FDA 510(k) clearance on 1997-07-25. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K972144.

When did SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III receive FDA 510(k) clearance?

SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III received FDA 510(k) clearance on 1997-07-25, under 510(k) number K972144.

Who is the listed applicant for SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III?

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 SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III?

The FDA product code for SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III is JBQ.

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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

View all 164 devices →

Related Devices (Code: JBQ)

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.

K242952INNOVANCE AntithrombinSiemens Healthcare Diagnostic Products GmbHK081769INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5Siemens Healthcare DiagnosticsK070301HEMOSIL ANTITHROMBINInstrumentation Laboratory COK062431HEMOSIL LIQUID ANTITHROMBINInstrumentation Laboratory COK043007BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105Hyphen BiomedK033775HEMOSIL LIQUID ANTITHROMBIN XLInstrumentation Laboratory CO

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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