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FDA 510(k)

ACA BILIRUBIN CALIBRATOR

K-Number: K771798 · 1977-10-28

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1977-10-28
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACA BILIRUBIN 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 1977-10-28 under 510(k) number K771798. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACA BILIRUBIN CALIBRATOR?

ACA BILIRUBIN CALIBRATOR is a medical device that received FDA 510(k) clearance on 1977-10-28. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K771798.

When did ACA BILIRUBIN CALIBRATOR receive FDA 510(k) clearance?

ACA BILIRUBIN CALIBRATOR received FDA 510(k) clearance on 1977-10-28, under 510(k) number K771798.

Who is the listed applicant for ACA BILIRUBIN 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 ACA BILIRUBIN CALIBRATOR?

The FDA product code for ACA BILIRUBIN CALIBRATOR is JJX.

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

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Related Devices (Code: JJX)

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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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