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FDA 510(k)

BACTERUERIA SCREENING PROCEDURE

K-Number: K832975 · 1983-11-14

ApplicantTurner Designs, Inc.
Decision Date1983-11-14
Product CodeJXA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BACTERUERIA SCREENING PROCEDURE is the device name listed in this FDA 510(k) record. The listed applicant is Turner Designs, Inc.. It received FDA 510(k) clearance on 1983-11-14 under 510(k) number K832975. 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 BACTERUERIA SCREENING PROCEDURE?

BACTERUERIA SCREENING PROCEDURE is a medical device that received FDA 510(k) clearance on 1983-11-14. The listed applicant is Turner Designs, Inc.. The 510(k) number is K832975.

When did BACTERUERIA SCREENING PROCEDURE receive FDA 510(k) clearance?

BACTERUERIA SCREENING PROCEDURE received FDA 510(k) clearance on 1983-11-14, under 510(k) number K832975.

Who is the listed applicant for BACTERUERIA SCREENING PROCEDURE?

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

What is the FDA product code for BACTERUERIA SCREENING PROCEDURE?

The FDA product code for BACTERUERIA SCREENING PROCEDURE is JXA.

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Other records listing Turner Designs, 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.

K803285PHOTOMETER

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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