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FDA 510(k)

REAGENT SYSTEM #350HDL, SIGMA PROCEDURE

K-Number: K790760 · 1979-05-23

ApplicantSigma Chemical Co.
Decision Date1979-05-23
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REAGENT SYSTEM #350HDL, SIGMA PROCEDURE 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 1979-05-23 under 510(k) number K790760. The device is classified under product code CHH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REAGENT SYSTEM #350HDL, SIGMA PROCEDURE?

REAGENT SYSTEM #350HDL, SIGMA PROCEDURE is a medical device that received FDA 510(k) clearance on 1979-05-23. The listed applicant is Sigma Chemical Co.. The 510(k) number is K790760.

When did REAGENT SYSTEM #350HDL, SIGMA PROCEDURE receive FDA 510(k) clearance?

REAGENT SYSTEM #350HDL, SIGMA PROCEDURE received FDA 510(k) clearance on 1979-05-23, under 510(k) number K790760.

Who is the listed applicant for REAGENT SYSTEM #350HDL, SIGMA PROCEDURE?

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 REAGENT SYSTEM #350HDL, SIGMA PROCEDURE?

The FDA product code for REAGENT SYSTEM #350HDL, SIGMA PROCEDURE is CHH.

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Other records listing Sigma Chemical Co. as applicant

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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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