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FDA 510(k)

SIGMA PROCEDURE #880 FIBRINOGIN/PLASMA

K-Number: K801926 · 1980-09-09

ApplicantSigma Chemical Co.
Decision Date1980-09-09
Product CodeKQJ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SIGMA PROCEDURE #880 FIBRINOGIN/PLASMA is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Chemical Co.. It received FDA 510(k) clearance on 1980-09-09 under 510(k) number K801926. 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 PROCEDURE #880 FIBRINOGIN/PLASMA?

SIGMA PROCEDURE #880 FIBRINOGIN/PLASMA is a medical device that received FDA 510(k) clearance on 1980-09-09. The listed applicant is Sigma Chemical Co.. The 510(k) number is K801926.

When did SIGMA PROCEDURE #880 FIBRINOGIN/PLASMA receive FDA 510(k) clearance?

SIGMA PROCEDURE #880 FIBRINOGIN/PLASMA received FDA 510(k) clearance on 1980-09-09, under 510(k) number K801926.

Who is the listed applicant for SIGMA PROCEDURE #880 FIBRINOGIN/PLASMA?

The FDA 510(k) record lists Sigma Chemical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIGMA PROCEDURE #880 FIBRINOGIN/PLASMA?

The FDA product code for SIGMA PROCEDURE #880 FIBRINOGIN/PLASMA is KQJ.

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Other records listing Sigma Chemical Co. 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.

K933694SIGMA GLUCOSE REAGENTK933678SIGMA CALCIUM REAGENTK933696SIGMA ELECTROLYTE REFERENCE REAGENTK933691SIGMA CO2 ALKALINE BUFFER REAGENTK933679SIGMA BUN REAGENTK933703SIGMA WASH CONCENTRATE SOLUTION

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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.K971858SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)Sigma Diagnostics, Inc.K970189FIF TMPanbio, Inc.K965113N-ASSAY TIA FIBRINOGEN TEST KITCrestat 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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