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FDA 510(k)

SILVER STAIN REAGENT SYSTEM

K-Number: K871476 · 1987-05-21

ApplicantSigma Chemical Co.
Decision Date1987-05-21
Product CodeLEF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SILVER STAIN REAGENT SYSTEM 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 1987-05-21 under 510(k) number K871476. The device is classified under product code LEF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SILVER STAIN REAGENT SYSTEM?

SILVER STAIN REAGENT SYSTEM is a medical device that received FDA 510(k) clearance on 1987-05-21. The listed applicant is Sigma Chemical Co.. The 510(k) number is K871476.

When did SILVER STAIN REAGENT SYSTEM receive FDA 510(k) clearance?

SILVER STAIN REAGENT SYSTEM received FDA 510(k) clearance on 1987-05-21, under 510(k) number K871476.

Who is the listed applicant for SILVER STAIN REAGENT SYSTEM?

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 SILVER STAIN REAGENT SYSTEM?

The FDA product code for SILVER STAIN REAGENT SYSTEM is LEF.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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