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FDA 510(k)

UPRO

K-Number: K981682 · 1998-09-21

ApplicantAbbott Laboratories
Decision Date1998-09-21
Product CodeJGQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UPRO is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1998-09-21 under 510(k) number K981682. The device is classified under product code JGQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UPRO?

UPRO is a medical device that received FDA 510(k) clearance on 1998-09-21. The listed applicant is Abbott Laboratories. The 510(k) number is K981682.

When did UPRO receive FDA 510(k) clearance?

UPRO received FDA 510(k) clearance on 1998-09-21, under 510(k) number K981682.

Who is the listed applicant for UPRO?

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 UPRO?

The FDA product code for UPRO is JGQ.

Other records listing Abbott Laboratories as applicant

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Related Devices (Code: JGQ)

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.

K131051HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB)Hitachi Chemical Diagnostics, Inc.K072638ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801Roche Diagnostics Corp.K071239TOTAL PROTEIN URINE/CSF GEN.3Roche DiagnosticsK981295UPROAbbott LaboratoriesK925794TRACE MICROPROTEIN REAGENTTrace America, Inc.K913615URINARY/CSF PROTEINBoehringer Mannheim Corp.

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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