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FDA 510(k)

RESUBMITTED UTISCREEN(TM) BACTERIAL ATP TEST

K-Number: K883385 · 1988-09-07

ApplicantLos Alamos Diagnostics
Decision Date1988-09-07
Product CodeJXA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RESUBMITTED UTISCREEN(TM) BACTERIAL ATP TEST 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 1988-09-07 under 510(k) number K883385. 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 RESUBMITTED UTISCREEN(TM) BACTERIAL ATP TEST?

RESUBMITTED UTISCREEN(TM) BACTERIAL ATP TEST is a medical device that received FDA 510(k) clearance on 1988-09-07. The listed applicant is Los Alamos Diagnostics. The 510(k) number is K883385.

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

RESUBMITTED UTISCREEN(TM) BACTERIAL ATP TEST received FDA 510(k) clearance on 1988-09-07, under 510(k) number K883385.

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

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 RESUBMITTED UTISCREEN(TM) BACTERIAL ATP TEST?

The FDA product code for RESUBMITTED UTISCREEN(TM) BACTERIAL ATP TEST 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) LUMINOMETERK882608LAD MODEL 633 LUMINOMETERK881439MODIFIED UTISCREEN(TM) BACTERIAL ATP TEST SYSTEMK874262LAD 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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