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FDA 510(k)

ACS TOBRAMYCIN

K-Number: K974029 · 1998-02-12

ApplicantChiron Diagnostics Corp.
Decision Date1998-02-12
Product CodeLCR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ACS TOBRAMYCIN is the device name listed in this FDA 510(k) record. The listed applicant is Chiron Diagnostics Corp.. It received FDA 510(k) clearance on 1998-02-12 under 510(k) number K974029. The device is classified under product code LCR. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACS TOBRAMYCIN?

ACS TOBRAMYCIN is a medical device that received FDA 510(k) clearance on 1998-02-12. The listed applicant is Chiron Diagnostics Corp.. The 510(k) number is K974029.

When did ACS TOBRAMYCIN receive FDA 510(k) clearance?

ACS TOBRAMYCIN received FDA 510(k) clearance on 1998-02-12, under 510(k) number K974029.

Who is the listed applicant for ACS TOBRAMYCIN?

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

What is the FDA product code for ACS TOBRAMYCIN?

The FDA product code for ACS TOBRAMYCIN is LCR.

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Other records listing Chiron Diagnostics Corp. 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.

K992157CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAYK991582CHIRON DIAGNOSTICS ACS: 180 FOLATEK991692CHIRON DIAGNOSTICS ACS: 180 FT3K982680CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAYK981478ACS:CENTAUR CEAK981839ACS:CENTAUR PSA2 IMMUNOASSAY

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Related Devices (Code: LCR)

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.

K060998QMS TOBRAMYCINSeradyn, Inc.K962818TOBRAMYCIN FLEX REAGENT CARTRIDGEDade Intl., Inc.K952568BECKMAN ARRAY TOBRAMYCIN (TOB) REAGENTBeckman Instruments, Inc.K911940OPUS(R) TOBRAMYCINPb Diagnostic Systems, Inc.K911613VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4Exmoor Plastics , Ltd.K854873INTRAOCULAR PRESSURE REDUCERMira, 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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