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FDA 510(k)

TDX NETILMICIN

K-Number: K821698 · 1982-06-22

ApplicantAbbott Laboratories
Decision Date1982-06-22
Product CodeLCE
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

TDX NETILMICIN is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1982-06-22 under 510(k) number K821698. The device is classified under product code LCE. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TDX NETILMICIN?

TDX NETILMICIN is a medical device that received FDA 510(k) clearance on 1982-06-22. The listed applicant is Abbott Laboratories. The 510(k) number is K821698.

When did TDX NETILMICIN receive FDA 510(k) clearance?

TDX NETILMICIN received FDA 510(k) clearance on 1982-06-22, under 510(k) number K821698.

Who is the listed applicant for TDX NETILMICIN?

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 TDX NETILMICIN?

The FDA product code for TDX NETILMICIN is LCE.

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Related Devices (Code: LCE)

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.

K833715EMIT NETILMICIN ASSAYSyva Co.K832088AMES TDA NETILMICIN TEST & SERUMMiles Laboratories, Inc.K822941NETILMICIN FLUORESCENT IMMUNOASSAYAmerican Diagnostic Corp.K821399MACRO-VUE CARD TEST, NETILMICINBd Becton Dickinson Vacutainer Systems PreanalyticK820324EMIT AND NETILMICIN ASSAYSyva Co.

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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