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FDA 510(k)

SIGMA PEROXIDASE MYELOPEROXIDASE STAINING PROCEDUR

K-Number: K844402 · 1985-01-04

ApplicantSigma Chemical Co.
Decision Date1985-01-04
Product CodeGIA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SIGMA PEROXIDASE MYELOPEROXIDASE STAINING PROCEDUR 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 1985-01-04 under 510(k) number K844402. 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 SIGMA PEROXIDASE MYELOPEROXIDASE STAINING PROCEDUR?

SIGMA PEROXIDASE MYELOPEROXIDASE STAINING PROCEDUR is a medical device that received FDA 510(k) clearance on 1985-01-04. The listed applicant is Sigma Chemical Co.. The 510(k) number is K844402.

When did SIGMA PEROXIDASE MYELOPEROXIDASE STAINING PROCEDUR receive FDA 510(k) clearance?

SIGMA PEROXIDASE MYELOPEROXIDASE STAINING PROCEDUR received FDA 510(k) clearance on 1985-01-04, under 510(k) number K844402.

Who is the listed applicant for SIGMA PEROXIDASE MYELOPEROXIDASE STAINING PROCEDUR?

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 PEROXIDASE MYELOPEROXIDASE STAINING PROCEDUR?

The FDA product code for SIGMA PEROXIDASE MYELOPEROXIDASE STAINING PROCEDUR 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 REAGENTK933691SIGMA CO2 ALKALINE BUFFER REAGENTK933679SIGMA BUN 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.K811011HISTOCHEMICAL DEMONSTRATION OF LEUKOCYTESigma 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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