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FDA 510(k)

UTISCREEN(R) BACTERIAL ATP TEST

K-Number: K864202 · 1987-02-13

ApplicantLos Alamos Diagnostics
Decision Date1987-02-13
Product CodeJXA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

UTISCREEN(R) 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 1987-02-13 under 510(k) number K864202. 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 UTISCREEN(R) BACTERIAL ATP TEST?

UTISCREEN(R) BACTERIAL ATP TEST is a medical device that received FDA 510(k) clearance on 1987-02-13. The listed applicant is Los Alamos Diagnostics. The 510(k) number is K864202.

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

UTISCREEN(R) BACTERIAL ATP TEST received FDA 510(k) clearance on 1987-02-13, under 510(k) number K864202.

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

The FDA product code for UTISCREEN(R) 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) LUMINOMETERK883385RESUBMITTED UTISCREEN(TM) BACTERIAL ATP TESTK882608LAD MODEL 633 LUMINOMETERK881439MODIFIED UTISCREEN(TM) BACTERIAL ATP TEST SYSTEMK874262LAD MODEL 735 LUMINOMETERK864201LAD MODEL 535 LUMINOMETER

View all 7 devices →

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.K950246MULTIPLE (IZON 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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