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FDA 510(k)

FLUOROMATIC TOBRAMYCIN FIA IMMUNOASSAY

K-Number: K791596 · 1979-10-17

ApplicantBio-Rad
Decision Date1979-10-17
Product CodeKLB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

FLUOROMATIC TOBRAMYCIN FIA IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1979-10-17 under 510(k) number K791596. The device is classified under product code KLB. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUOROMATIC TOBRAMYCIN FIA IMMUNOASSAY?

FLUOROMATIC TOBRAMYCIN FIA IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1979-10-17. The listed applicant is Bio-Rad. The 510(k) number is K791596.

When did FLUOROMATIC TOBRAMYCIN FIA IMMUNOASSAY receive FDA 510(k) clearance?

FLUOROMATIC TOBRAMYCIN FIA IMMUNOASSAY received FDA 510(k) clearance on 1979-10-17, under 510(k) number K791596.

Who is the listed applicant for FLUOROMATIC TOBRAMYCIN FIA IMMUNOASSAY?

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

What is the FDA product code for FLUOROMATIC TOBRAMYCIN FIA IMMUNOASSAY?

The FDA product code for FLUOROMATIC TOBRAMYCIN FIA IMMUNOASSAY is KLB.

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Other records listing Bio-Rad 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.

K171061MRSASelect IIK122187VRESELECT CULTURE MEDIUMK103684VRESELECT CULTURE MEDIUMK093678PLATELIA ASPERGILLUS EIA MODEL 62793K100589MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENSK081362PLATELIA LYME IGM

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Related Devices (Code: KLB)

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.

K060853ONLINE TDM TOBRAMYCINRoche Diagnostics Corp.K012312IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS)Diagnostic Products Corp.K003341EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORSSyva Co., Dade Behring, Inc.K904304DUPONT DIMENSION(R) TOBRAMLLYCIN(TOBR) METHODE.I. Dupont DE Nemours & Co., Inc.K903192IL TOBRAMYCIN ASSAYInstrumentation Laboratory COK893913TECHNICON RA SYSTEMS TOBRAMYCIN TEST METHODTechnicon Instruments Corp.

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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