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FDA 510(k)

SUDAN IV HERXHEIMER

K-Number: K842916 · 1984-09-11

ApplicantE K Ind., Inc.
Decision Date1984-09-11
Product CodeKKK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SUDAN IV HERXHEIMER is the device name listed in this FDA 510(k) record. The listed applicant is E K Ind., Inc.. It received FDA 510(k) clearance on 1984-09-11 under 510(k) number K842916. The device is classified under product code KKK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUDAN IV HERXHEIMER?

SUDAN IV HERXHEIMER is a medical device that received FDA 510(k) clearance on 1984-09-11. The listed applicant is E K Ind., Inc.. The 510(k) number is K842916.

When did SUDAN IV HERXHEIMER receive FDA 510(k) clearance?

SUDAN IV HERXHEIMER received FDA 510(k) clearance on 1984-09-11, under 510(k) number K842916.

Who is the listed applicant for SUDAN IV HERXHEIMER?

The FDA 510(k) record lists E K Ind., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUDAN IV HERXHEIMER?

The FDA product code for SUDAN IV HERXHEIMER is KKK.

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Other records listing E K Ind., Inc. 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.

K842931DRABKIN REAGENTK842938ACETIC ACID 1% V/VK842934DECOLORIZING FLUIC, ACID-ALCOHOL 3%K842937ACETIC ACID 2% V/VK842935ACETIC ACID, 5% V/VK842936ACETIC ACID, 3% V/V

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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