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FDA 510(k)

RAPID BACTERIURIA SCREENING TEST

K-Number: K820126 · 1983-01-07

ApplicantAnalytical Luminescence Laboratory, Inc.
Decision Date1983-01-07
Product CodeJXA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RAPID BACTERIURIA SCREENING TEST is the device name listed in this FDA 510(k) record. The listed applicant is Analytical Luminescence Laboratory, Inc.. It received FDA 510(k) clearance on 1983-01-07 under 510(k) number K820126. 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 SCREENING TEST?

RAPID BACTERIURIA SCREENING TEST is a medical device that received FDA 510(k) clearance on 1983-01-07. The listed applicant is Analytical Luminescence Laboratory, Inc.. The 510(k) number is K820126.

When did RAPID BACTERIURIA SCREENING TEST receive FDA 510(k) clearance?

RAPID BACTERIURIA SCREENING TEST received FDA 510(k) clearance on 1983-01-07, under 510(k) number K820126.

Who is the listed applicant for RAPID BACTERIURIA SCREENING TEST?

The FDA 510(k) record lists Analytical Luminescence Laboratory, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RAPID BACTERIURIA SCREENING TEST?

The FDA product code for RAPID BACTERIURIA SCREENING TEST is JXA.

Related Clinical Trials

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Other records listing Analytical Luminescence Laboratory, Inc. 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.

K851387MICROSTATIC URINE TRANSPORT TUBE FOR C & S

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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