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FDA 510(k)

COLORIMETRIC DETERM. SOCITRATE DEHYDRO.

K-Number: K770902 · 1977-07-14

ApplicantSigma Chemical Co.
Decision Date1977-07-14
Product CodeJKH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COLORIMETRIC DETERM. SOCITRATE DEHYDRO. 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 1977-07-14 under 510(k) number K770902. The device is classified under product code JKH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLORIMETRIC DETERM. SOCITRATE DEHYDRO.?

COLORIMETRIC DETERM. SOCITRATE DEHYDRO. is a medical device that received FDA 510(k) clearance on 1977-07-14. The listed applicant is Sigma Chemical Co.. The 510(k) number is K770902.

When did COLORIMETRIC DETERM. SOCITRATE DEHYDRO. receive FDA 510(k) clearance?

COLORIMETRIC DETERM. SOCITRATE DEHYDRO. received FDA 510(k) clearance on 1977-07-14, under 510(k) number K770902.

Who is the listed applicant for COLORIMETRIC DETERM. SOCITRATE DEHYDRO.?

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 COLORIMETRIC DETERM. SOCITRATE DEHYDRO.?

The FDA product code for COLORIMETRIC DETERM. SOCITRATE DEHYDRO. is JKH.

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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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