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FDA 510(k)

REAGENT SYSTEM

K-Number: K760821 · 1976-10-21

ApplicantSigma Chemical Co.
Decision Date1976-10-21
Product CodeCJT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

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 1976-10-21 under 510(k) number K760821. The device is classified under product code CJT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REAGENT SYSTEM?

REAGENT SYSTEM is a medical device that received FDA 510(k) clearance on 1976-10-21. The listed applicant is Sigma Chemical Co.. The 510(k) number is K760821.

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

REAGENT SYSTEM received FDA 510(k) clearance on 1976-10-21, under 510(k) number K760821.

Who is the listed applicant for 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 REAGENT SYSTEM?

The FDA product code for REAGENT SYSTEM is CJT.

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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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