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FDA 510(k)

MODIFIED UTISCREEN(TM) BACTERIAL ATP TEST SYSTEM

K-Number: K881439 · 1988-04-28

ApplicantLos Alamos Diagnostics
Decision Date1988-04-28
Product CodeJXA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MODIFIED UTISCREEN(TM) BACTERIAL ATP TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Los Alamos Diagnostics. It received FDA 510(k) clearance on 1988-04-28 under 510(k) number K881439. 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 MODIFIED UTISCREEN(TM) BACTERIAL ATP TEST SYSTEM?

MODIFIED UTISCREEN(TM) BACTERIAL ATP TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1988-04-28. The listed applicant is Los Alamos Diagnostics. The 510(k) number is K881439.

When did MODIFIED UTISCREEN(TM) BACTERIAL ATP TEST SYSTEM receive FDA 510(k) clearance?

MODIFIED UTISCREEN(TM) BACTERIAL ATP TEST SYSTEM received FDA 510(k) clearance on 1988-04-28, under 510(k) number K881439.

Who is the listed applicant for MODIFIED UTISCREEN(TM) BACTERIAL ATP TEST SYSTEM?

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

What is the FDA product code for MODIFIED UTISCREEN(TM) BACTERIAL ATP TEST SYSTEM?

The FDA product code for MODIFIED UTISCREEN(TM) BACTERIAL ATP TEST SYSTEM is JXA.

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Other records listing Los Alamos Diagnostics 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.

K896117MODIFIED MODEL 535(TM) LUMINOMETERK883385RESUBMITTED UTISCREEN(TM) BACTERIAL ATP TESTK882608LAD MODEL 633 LUMINOMETERK874262LAD MODEL 735 LUMINOMETERK864202UTISCREEN(R) BACTERIAL ATP TESTK864201LAD MODEL 535 LUMINOMETER

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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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