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FDA 510(k)

ACE ALBUMIN CALIBRATOR

K-Number: K821061 · 1982-05-03

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1982-05-03
Product CodeJIS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACE ALBUMIN CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. It received FDA 510(k) clearance on 1982-05-03 under 510(k) number K821061. The device is classified under product code JIS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACE ALBUMIN CALIBRATOR?

ACE ALBUMIN CALIBRATOR is a medical device that received FDA 510(k) clearance on 1982-05-03. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K821061.

When did ACE ALBUMIN CALIBRATOR receive FDA 510(k) clearance?

ACE ALBUMIN CALIBRATOR received FDA 510(k) clearance on 1982-05-03, under 510(k) number K821061.

Who is the listed applicant for ACE ALBUMIN CALIBRATOR?

The FDA 510(k) record lists E.I. Dupont DE Nemours & Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACE ALBUMIN CALIBRATOR?

The FDA product code for ACE ALBUMIN CALIBRATOR is JIS.

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Other records listing E.I. Dupont DE Nemours & Co., Inc. as applicant

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Related Devices (Code: JIS)

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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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