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FDA 510(k)

PONCEAU S CONCENTRATE

K-Number: K771777 · 1977-10-25

ApplicantSigma Chemical Co.
Decision Date1977-10-25
Product CodeHZO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PONCEAU S CONCENTRATE 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 1977-10-25 under 510(k) number K771777. The device is classified under product code HZO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PONCEAU S CONCENTRATE?

PONCEAU S CONCENTRATE is a medical device that received FDA 510(k) clearance on 1977-10-25. The listed applicant is Sigma Chemical Co.. The 510(k) number is K771777.

When did PONCEAU S CONCENTRATE receive FDA 510(k) clearance?

PONCEAU S CONCENTRATE received FDA 510(k) clearance on 1977-10-25, under 510(k) number K771777.

Who is the listed applicant for PONCEAU S CONCENTRATE?

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 PONCEAU S CONCENTRATE?

The FDA product code for PONCEAU S CONCENTRATE is HZO.

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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

View all 231 devices →

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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