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FDA 510(k)

NEUTRAL RED

K-Number: K871477 · 1987-04-29

ApplicantSigma Chemical Co.
Decision Date1987-04-29
Product CodeKFE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

NEUTRAL RED 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 1987-04-29 under 510(k) number K871477. The device is classified under product code KFE. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEUTRAL RED?

NEUTRAL RED is a medical device that received FDA 510(k) clearance on 1987-04-29. The listed applicant is Sigma Chemical Co.. The 510(k) number is K871477.

When did NEUTRAL RED receive FDA 510(k) clearance?

NEUTRAL RED received FDA 510(k) clearance on 1987-04-29, under 510(k) number K871477.

Who is the listed applicant for NEUTRAL RED?

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 NEUTRAL RED?

The FDA product code for NEUTRAL RED is KFE.

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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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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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