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FDA 510(k)

QUANTI. COLORI. DET. OF SERUM IRON

K-Number: K770495 · 1977-06-08

ApplicantSigma Chemical Co.
Decision Date1977-06-08
Product Code
DecisionSubstantially Equivalent

Device Summary

QUANTI. COLORI. DET. OF SERUM IRON 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 1977-06-08 under 510(k) number K770495. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTI. COLORI. DET. OF SERUM IRON?

QUANTI. COLORI. DET. OF SERUM IRON is a medical device that received FDA 510(k) clearance on 1977-06-08. The listed applicant is Sigma Chemical Co.. The 510(k) number is K770495.

When did QUANTI. COLORI. DET. OF SERUM IRON receive FDA 510(k) clearance?

QUANTI. COLORI. DET. OF SERUM IRON received FDA 510(k) clearance on 1977-06-08, under 510(k) number K770495.

Who is the listed applicant for QUANTI. COLORI. DET. OF SERUM IRON?

The FDA 510(k) record lists Sigma Chemical Co. as the applicant. This does not by itself establish the device manufacturer.

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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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