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FDA 510(k)

SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)

K-Number: K971858 · 1997-10-09

ApplicantSigma Diagnostics, Inc.
Decision Date1997-10-09
Product CodeKQJ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A) 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 1997-10-09 under 510(k) number K971858. The device is classified under product code KQJ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)?

SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A) is a medical device that received FDA 510(k) clearance on 1997-10-09. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K971858.

When did SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A) receive FDA 510(k) clearance?

SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A) received FDA 510(k) clearance on 1997-10-09, under 510(k) number K971858.

Who is the listed applicant for SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)?

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 FIBRINOGEN KIT (886A/887A)?

The FDA product code for SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A) is KQJ.

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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: KQJ)

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.

K251968HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XLInstrumentation Laboratory (IL) Co.K073367HEMOSIL FIBRINOGEN-CInstrumentation Laboratory COK050928DADE THROMBIN REAGENTDade Behring, Inc.K970189FIF TMPanbio, Inc.K965113N-ASSAY TIA FIBRINOGEN TEST KITCrestat Diagnostics, Inc.K934326MULTIFIBREN UBehring Diagnostics, Inc.

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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