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FDA 510(k)

HISTOCHEMICAL DEMONSTRATION OF LEUKOCYTE

K-Number: K811011 · 1981-05-15

ApplicantSigma Chemical Co.
Decision Date1981-05-15
Product CodeGIA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HISTOCHEMICAL DEMONSTRATION OF LEUKOCYTE 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 1981-05-15 under 510(k) number K811011. The device is classified under product code GIA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HISTOCHEMICAL DEMONSTRATION OF LEUKOCYTE?

HISTOCHEMICAL DEMONSTRATION OF LEUKOCYTE is a medical device that received FDA 510(k) clearance on 1981-05-15. The listed applicant is Sigma Chemical Co.. The 510(k) number is K811011.

When did HISTOCHEMICAL DEMONSTRATION OF LEUKOCYTE receive FDA 510(k) clearance?

HISTOCHEMICAL DEMONSTRATION OF LEUKOCYTE received FDA 510(k) clearance on 1981-05-15, under 510(k) number K811011.

Who is the listed applicant for HISTOCHEMICAL DEMONSTRATION OF LEUKOCYTE?

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 HISTOCHEMICAL DEMONSTRATION OF LEUKOCYTE?

The FDA product code for HISTOCHEMICAL DEMONSTRATION OF LEUKOCYTE is GIA.

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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 REAGENTK933679SIGMA BUN REAGENTK933691SIGMA CO2 ALKALINE BUFFER REAGENTK933703SIGMA WASH CONCENTRATE SOLUTION

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Related Devices (Code: GIA)

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.

K931241FAST'N'FLAMMATORY KITTechlab, Inc.K844402SIGMA PEROXIDASE MYELOPEROXIDASE STAINING PROCEDURSigma Chemical 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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