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FDA 510(k)

SIGMA SUDAN BLACK REAGENT 380-1

K-Number: K843684 · 1984-10-31

Decision Date1984-10-31
Product CodeHZZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SIGMA SUDAN BLACK REAGENT 380-1 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 1984-10-31 under 510(k) number K843684. The device is classified under product code HZZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIGMA SUDAN BLACK REAGENT 380-1?

SIGMA SUDAN BLACK REAGENT 380-1 is a medical device that received FDA 510(k) clearance on 1984-10-31. The listed applicant is Sigma Chemical Co.. The 510(k) number is K843684.

When did SIGMA SUDAN BLACK REAGENT 380-1 receive FDA 510(k) clearance?

SIGMA SUDAN BLACK REAGENT 380-1 received FDA 510(k) clearance on 1984-10-31, under 510(k) number K843684.

Who is the listed applicant for SIGMA SUDAN BLACK REAGENT 380-1?

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 SIGMA SUDAN BLACK REAGENT 380-1?

The FDA product code for SIGMA SUDAN BLACK REAGENT 380-1 is HZZ.

Related Clinical Trials

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.

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.

View all 231 devices →

Related Devices (Code: HZZ)

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.

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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