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FDA 510(k)

RIM-UREA

K-Number: K843571 · 1984-10-01

ApplicantAustin Biological Laboratories
Decision Date1984-10-01
Product CodeJSS
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RIM-UREA is the device name listed in this FDA 510(k) record. The listed applicant is Austin Biological Laboratories. It received FDA 510(k) clearance on 1984-10-01 under 510(k) number K843571. The device is classified under product code JSS. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RIM-UREA?

RIM-UREA is a medical device that received FDA 510(k) clearance on 1984-10-01. The listed applicant is Austin Biological Laboratories. The 510(k) number is K843571.

When did RIM-UREA receive FDA 510(k) clearance?

RIM-UREA received FDA 510(k) clearance on 1984-10-01, under 510(k) number K843571.

Who is the listed applicant for RIM-UREA?

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

What is the FDA product code for RIM-UREA?

The FDA product code for RIM-UREA is JSS.

Other records listing Austin Biological Laboratories as applicant

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.

K880511XACT NEISSERIAK874727PRECEPT(TM) CIPROFLOXACINK870769AUSTIN NONFERMENTER KITK864069PRECEPT (TM) TICARCILLIN/CLAVULANIC ACIDK862446PRECEPT CEFTAZIDIMEK862560PRECEPT CEFTIZOXIME

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Related Devices (Code: JSS)

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.

K123418GRAM-NEGATIVE QUICKFISH BCAdvandx, Inc.K101558GNR TRAFFIC LIGHT PNA FISHAdvandx, Inc.K092236E.COLI/P. AERUGINOSA PNA FISHAdvandx, Inc.K092393EK/P. AERUGINOSA PNA FISHAdvandx, Inc.K082068E. COLI PNA FISHAdvandx, Inc.K081433EK/P. AERUGINOSA PNA FISHAdvandx, Inc.

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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