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FDA 510(k)

CEDIA(R) TOBRAMYCIN ASSAY

K-Number: K912143 · 1991-07-26

ApplicantMicrogenics Corp.
Decision Date1991-07-26
Product CodeLFW
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CEDIA(R) TOBRAMYCIN ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Microgenics Corp.. It received FDA 510(k) clearance on 1991-07-26 under 510(k) number K912143. The device is classified under product code LFW. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CEDIA(R) TOBRAMYCIN ASSAY?

CEDIA(R) TOBRAMYCIN ASSAY is a medical device that received FDA 510(k) clearance on 1991-07-26. The listed applicant is Microgenics Corp.. The 510(k) number is K912143.

When did CEDIA(R) TOBRAMYCIN ASSAY receive FDA 510(k) clearance?

CEDIA(R) TOBRAMYCIN ASSAY received FDA 510(k) clearance on 1991-07-26, under 510(k) number K912143.

Who is the listed applicant for CEDIA(R) TOBRAMYCIN ASSAY?

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

What is the FDA product code for CEDIA(R) TOBRAMYCIN ASSAY?

The FDA product code for CEDIA(R) TOBRAMYCIN ASSAY is LFW.

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Other records listing Microgenics Corp. as applicant

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Related Devices (Code: LFW)

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.

K964670ROCHE COBAS-FP REAGENTS FOR TOBRAMYCINRoche Diagnostic Systems, Inc.K944371TOBRAMYCIN FPIA REAGENT SET AND CALIBRATORSigma Diagnostics, Inc.K941614AXSYM TOBRAMYCINAbbott LaboratoriesK900707MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATORInnotron of Oregon, Inc.K894531FPR TOBRAMYCIN KITColony Laboratories, Inc.K872562INNOTRON INNOFLUOR TOBRAMYCIN REAGENT SETInnotron of Oregon, 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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