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FDA 510(k)

RAPID BACTERIURIA SCREEN (RBS)

K-Number: K862195 · 1986-06-30

ApplicantNew Horizons Diagnostics Co.
Decision Date1986-06-30
Product CodeJXA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RAPID BACTERIURIA SCREEN (RBS) is the device name listed in this FDA 510(k) record. The listed applicant is New Horizons Diagnostics Co.. It received FDA 510(k) clearance on 1986-06-30 under 510(k) number K862195. The device is classified under product code JXA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAPID BACTERIURIA SCREEN (RBS)?

RAPID BACTERIURIA SCREEN (RBS) is a medical device that received FDA 510(k) clearance on 1986-06-30. The listed applicant is New Horizons Diagnostics Co.. The 510(k) number is K862195.

When did RAPID BACTERIURIA SCREEN (RBS) receive FDA 510(k) clearance?

RAPID BACTERIURIA SCREEN (RBS) received FDA 510(k) clearance on 1986-06-30, under 510(k) number K862195.

Who is the listed applicant for RAPID BACTERIURIA SCREEN (RBS)?

The FDA 510(k) record lists New Horizons Diagnostics Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RAPID BACTERIURIA SCREEN (RBS)?

The FDA product code for RAPID BACTERIURIA SCREEN (RBS) is JXA.

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Other records listing New Horizons Diagnostics Co. 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.

K932622CHOLERA SMART(TM)K925190PYLORISCREENK922432CHOLERASCREENK874761RAPID COLORIMETRIC DIRECT STREP A TESTK871226SYPHILIS SEROLOGICAL REAGENTSK871105THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE

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Related Devices (Code: JXA)

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.

K011043OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)OsmetechK981084URISCREENDiatech Diagnostics,Inc.K972676URINE SCREENING DEVICECombact Diagnostic Systems , Ltd.K952246TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KITTri-Tech, Inc.K950257MULTIPLE (IZON DBS & URINE COLLECTION KIT)Izon Business Products, Inc.K950221MULTIPLE (IZON BLOOD & URINE COLLECTION KIT)Izon Business Products, 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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