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FDA 510(k)

SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM

K-Number: K972796 · 1997-10-10

ApplicantSigma Diagnostics, Inc.
Decision Date1997-10-10
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM 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 1997-10-10 under 510(k) number K972796. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM?

SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM is a medical device that received FDA 510(k) clearance on 1997-10-10. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K972796.

When did SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM receive FDA 510(k) clearance?

SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM received FDA 510(k) clearance on 1997-10-10, under 510(k) number K972796.

Who is the listed applicant for SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM?

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 THROMBOMAX WITH CALCIUM?

The FDA product code for SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM is GJS.

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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: GJS)

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.

K253188CoaguChek XS Plus SystemRoche DiagnosticsK251564microINR SystemIline Microsystems, S.L.K243543microINR SystemIline Microsystems, S.L.K230802Xprecia Prime Coagulation SystemUniversal Biosensors Pty, Ltd.K220282i-STAT PTplus Cartridge with the i-STAT 1 SystemAbbott LaboratoriesK231711microINR SystemIline Microsystems, S.L.

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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