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FDA 510(k)

REAGENT SYSTEM 153-UV

K-Number: K770519 · 1977-06-03

ApplicantSigma Chemical Co.
Decision Date1977-06-03
Product CodeJKG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REAGENT SYSTEM 153-UV 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 1977-06-03 under 510(k) number K770519. The device is classified under product code JKG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REAGENT SYSTEM 153-UV?

REAGENT SYSTEM 153-UV is a medical device that received FDA 510(k) clearance on 1977-06-03. The listed applicant is Sigma Chemical Co.. The 510(k) number is K770519.

When did REAGENT SYSTEM 153-UV receive FDA 510(k) clearance?

REAGENT SYSTEM 153-UV received FDA 510(k) clearance on 1977-06-03, under 510(k) number K770519.

Who is the listed applicant for REAGENT SYSTEM 153-UV?

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 153-UV?

The FDA product code for REAGENT SYSTEM 153-UV is JKG.

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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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