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FDA 510(k)

DIASLIDE URINE CULTURING DEVICE

K-Number: K921045 · 1992-09-28

ApplicantSavyon Diagnostics , Ltd.
Decision Date1992-09-28
Product CodeJXA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DIASLIDE URINE CULTURING DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Savyon Diagnostics , Ltd.. It received FDA 510(k) clearance on 1992-09-28 under 510(k) number K921045. 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 DIASLIDE URINE CULTURING DEVICE?

DIASLIDE URINE CULTURING DEVICE is a medical device that received FDA 510(k) clearance on 1992-09-28. The listed applicant is Savyon Diagnostics , Ltd.. The 510(k) number is K921045.

When did DIASLIDE URINE CULTURING DEVICE receive FDA 510(k) clearance?

DIASLIDE URINE CULTURING DEVICE received FDA 510(k) clearance on 1992-09-28, under 510(k) number K921045.

Who is the listed applicant for DIASLIDE URINE CULTURING DEVICE?

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

What is the FDA product code for DIASLIDE URINE CULTURING DEVICE?

The FDA product code for DIASLIDE URINE CULTURING DEVICE is JXA.

Related Clinical Trials

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.

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Other records listing Savyon Diagnostics , Ltd. 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.

K914327SEROELISA(TM) CHLAMYDIA IGA TEST KITK915281SEROLISA CHLAMYDIA IGG TEST KITK910644IPAZYME (TM) CHLAMYDIA IGG-IGAK901975IPAZYME(TM) CHLAMYDIA TRUE IGM(TM)

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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