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FDA 510(k)

BOUINS SOLUTION

K-Number: K833515 · 1983-11-14

ApplicantSigma Chemical Co.
Decision Date1983-11-14
Product CodeIGN
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

BOUINS SOLUTION 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 1983-11-14 under 510(k) number K833515. The device is classified under product code IGN. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOUINS SOLUTION?

BOUINS SOLUTION is a medical device that received FDA 510(k) clearance on 1983-11-14. The listed applicant is Sigma Chemical Co.. The 510(k) number is K833515.

When did BOUINS SOLUTION receive FDA 510(k) clearance?

BOUINS SOLUTION received FDA 510(k) clearance on 1983-11-14, under 510(k) number K833515.

Who is the listed applicant for BOUINS SOLUTION?

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 BOUINS SOLUTION?

The FDA product code for BOUINS SOLUTION is IGN.

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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: IGN)

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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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