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FDA 510(k)

GLUCOSE REAGENT SYS, SIGMA PROCED. 115

K-Number: K760247 · 1976-08-26

ApplicantSigma Chemical Co.
Decision Date1976-08-26
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE REAGENT SYS, SIGMA PROCED. 115 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 1976-08-26 under 510(k) number K760247. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLUCOSE REAGENT SYS, SIGMA PROCED. 115?

GLUCOSE REAGENT SYS, SIGMA PROCED. 115 is a medical device that received FDA 510(k) clearance on 1976-08-26. The listed applicant is Sigma Chemical Co.. The 510(k) number is K760247.

When did GLUCOSE REAGENT SYS, SIGMA PROCED. 115 receive FDA 510(k) clearance?

GLUCOSE REAGENT SYS, SIGMA PROCED. 115 received FDA 510(k) clearance on 1976-08-26, under 510(k) number K760247.

Who is the listed applicant for GLUCOSE REAGENT SYS, SIGMA PROCED. 115?

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 GLUCOSE REAGENT SYS, SIGMA PROCED. 115?

The FDA product code for GLUCOSE REAGENT SYS, SIGMA PROCED. 115 is CFR.

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Other records listing Sigma Chemical Co. as applicant

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Related Devices (Code: CFR)

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.

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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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