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FDA 510(k)

UALB

K-Number: K983774 · 1999-01-28

ApplicantAbbott Laboratories
Decision Date1999-01-28
Product CodeJIR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UALB is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1999-01-28 under 510(k) number K983774. The device is classified under product code JIR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UALB?

UALB is a medical device that received FDA 510(k) clearance on 1999-01-28. The listed applicant is Abbott Laboratories. The 510(k) number is K983774.

When did UALB receive FDA 510(k) clearance?

UALB received FDA 510(k) clearance on 1999-01-28, under 510(k) number K983774.

Who is the listed applicant for UALB?

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 UALB?

The FDA product code for UALB is JIR.

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Related Devices (Code: JIR)

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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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