FDA 510(k)

ABBOTT A-GENT NEONATAL BILIRUBIN REAGENT

K-Number: K880743 · 1988-04-05

Decision Date1988-04-05

Product CodeCIG

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ABBOTT A-GENT NEONATAL BILIRUBIN REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1988-04-05 under 510(k) number K880743. The device is classified under product code CIG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABBOTT A-GENT NEONATAL BILIRUBIN REAGENT?

ABBOTT A-GENT NEONATAL BILIRUBIN REAGENT is a medical device that received FDA 510(k) clearance on 1988-04-05. The listed applicant is Abbott Laboratories. The 510(k) number is K880743.

When did ABBOTT A-GENT NEONATAL BILIRUBIN REAGENT receive FDA 510(k) clearance?

ABBOTT A-GENT NEONATAL BILIRUBIN REAGENT received FDA 510(k) clearance on 1988-04-05, under 510(k) number K880743.

Who is the listed applicant for ABBOTT A-GENT NEONATAL BILIRUBIN REAGENT?

The FDA 510(k) record lists Abbott Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ABBOTT A-GENT NEONATAL BILIRUBIN REAGENT?

The FDA product code for ABBOTT A-GENT NEONATAL BILIRUBIN REAGENT is CIG.

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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.