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FDA 510(k)

MS-2 AUTOMATED URINE SCREENING SYSTEM

K-Number: K781370 · 1978-09-20

ApplicantAbbott Laboratories
Decision Date1978-09-20
Product CodeJXA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MS-2 AUTOMATED URINE SCREENING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1978-09-20 under 510(k) number K781370. 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 MS-2 AUTOMATED URINE SCREENING SYSTEM?

MS-2 AUTOMATED URINE SCREENING SYSTEM is a medical device that received FDA 510(k) clearance on 1978-09-20. The listed applicant is Abbott Laboratories. The 510(k) number is K781370.

When did MS-2 AUTOMATED URINE SCREENING SYSTEM receive FDA 510(k) clearance?

MS-2 AUTOMATED URINE SCREENING SYSTEM received FDA 510(k) clearance on 1978-09-20, under 510(k) number K781370.

Who is the listed applicant for MS-2 AUTOMATED URINE SCREENING SYSTEM?

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

What is the FDA product code for MS-2 AUTOMATED URINE SCREENING SYSTEM?

The FDA product code for MS-2 AUTOMATED URINE SCREENING SYSTEM is JXA.

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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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