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FDA 510(k)

TECHNICON RA SYSTEMS/TOBRAMYCIN & GENTAMICIN

K-Number: K860868 · 1986-04-03

ApplicantTechnicon Instruments Corp.
Decision Date1986-04-03
Product CodeLCD
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

TECHNICON RA SYSTEMS/TOBRAMYCIN & GENTAMICIN is the device name listed in this FDA 510(k) record. The listed applicant is Technicon Instruments Corp.. It received FDA 510(k) clearance on 1986-04-03 under 510(k) number K860868. 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 TECHNICON RA SYSTEMS/TOBRAMYCIN & GENTAMICIN?

TECHNICON RA SYSTEMS/TOBRAMYCIN & GENTAMICIN is a medical device that received FDA 510(k) clearance on 1986-04-03. The listed applicant is Technicon Instruments Corp.. The 510(k) number is K860868.

When did TECHNICON RA SYSTEMS/TOBRAMYCIN & GENTAMICIN receive FDA 510(k) clearance?

TECHNICON RA SYSTEMS/TOBRAMYCIN & GENTAMICIN received FDA 510(k) clearance on 1986-04-03, under 510(k) number K860868.

Who is the listed applicant for TECHNICON RA SYSTEMS/TOBRAMYCIN & GENTAMICIN?

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

What is the FDA product code for TECHNICON RA SYSTEMS/TOBRAMYCIN & GENTAMICIN?

The FDA product code for TECHNICON RA SYSTEMS/TOBRAMYCIN & GENTAMICIN is LCD.

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Other records listing Technicon Instruments Corp. as applicant

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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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