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FDA 510(k)

SIGMA DIAGNOSTICS ACCUCLOT CONTROL II

K-Number: K981254 · 1998-04-29

ApplicantSigma Diagnostics, Inc.
Decision Date1998-04-29
Product CodeGGN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SIGMA DIAGNOSTICS ACCUCLOT CONTROL II 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 1998-04-29 under 510(k) number K981254. The device is classified under product code GGN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIGMA DIAGNOSTICS ACCUCLOT CONTROL II?

SIGMA DIAGNOSTICS ACCUCLOT CONTROL II is a medical device that received FDA 510(k) clearance on 1998-04-29. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K981254.

When did SIGMA DIAGNOSTICS ACCUCLOT CONTROL II receive FDA 510(k) clearance?

SIGMA DIAGNOSTICS ACCUCLOT CONTROL II received FDA 510(k) clearance on 1998-04-29, under 510(k) number K981254.

Who is the listed applicant for SIGMA DIAGNOSTICS ACCUCLOT CONTROL II?

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 ACCUCLOT CONTROL II?

The FDA product code for SIGMA DIAGNOSTICS ACCUCLOT CONTROL II is GGN.

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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: GGN)

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.

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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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