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FDA 510(k)

IL GENTAMICIN ASSAY SYSTEM

K-Number: K903743 · 1990-09-17

ApplicantInstrumentation Laboratory CO
Decision Date1990-09-17
Product CodeLCD
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

IL GENTAMICIN ASSAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 1990-09-17 under 510(k) number K903743. The device is classified under product code LCD. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IL GENTAMICIN ASSAY SYSTEM?

IL GENTAMICIN ASSAY SYSTEM is a medical device that received FDA 510(k) clearance on 1990-09-17. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K903743.

When did IL GENTAMICIN ASSAY SYSTEM receive FDA 510(k) clearance?

IL GENTAMICIN ASSAY SYSTEM received FDA 510(k) clearance on 1990-09-17, under 510(k) number K903743.

Who is the listed applicant for IL GENTAMICIN ASSAY SYSTEM?

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

What is the FDA product code for IL GENTAMICIN ASSAY SYSTEM?

The FDA product code for IL GENTAMICIN ASSAY SYSTEM is LCD.

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Other records listing Instrumentation Laboratory CO 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.

K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMK223187HemosIL Liquid Anti-XaK223090GEM Premier ChemSTATK223402HemosIL von Willebrand Factor AntigenK213464HemosIL Liquid Anti-XaK213426HemosIL ReadiPlasTin

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Related Devices (Code: LCD)

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.

K243500ARCHITECT iGentamicinAbbott LaboratoriesK102699ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORSAbbott LaboratoriesK060709MULTIGENT GENTAMICINSeradyn, Inc.K042479VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14; VITROS CHEOrtho-Clinical Diagnostics, Inc.K020704ROCHE ONLINE GENTAMICINRoche Diagnostics Corp.K012978RANDOX GENTAMICINRandox Laboratories, Ltd.

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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