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FDA 510(k)

MRI TOBRAMYCIN RIA KIT

K-Number: K813516 · 1981-12-29

ApplicantMicroanalytic Research, Inc.
Decision Date1981-12-29
Product CodeKLB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

MRI TOBRAMYCIN RIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Microanalytic Research, Inc.. It received FDA 510(k) clearance on 1981-12-29 under 510(k) number K813516. 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 MRI TOBRAMYCIN RIA KIT?

MRI TOBRAMYCIN RIA KIT is a medical device that received FDA 510(k) clearance on 1981-12-29. The listed applicant is Microanalytic Research, Inc.. The 510(k) number is K813516.

When did MRI TOBRAMYCIN RIA KIT receive FDA 510(k) clearance?

MRI TOBRAMYCIN RIA KIT received FDA 510(k) clearance on 1981-12-29, under 510(k) number K813516.

Who is the listed applicant for MRI TOBRAMYCIN RIA KIT?

The FDA 510(k) record lists Microanalytic Research, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MRI TOBRAMYCIN RIA KIT?

The FDA product code for MRI TOBRAMYCIN RIA KIT is KLB.

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Other records listing Microanalytic Research, Inc. 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.

K861097TRYPSIN RIA KITK820741MR1 LUTROPIN RIA KITK820740MR1 FOLLITROPIN RIA KITK812394MRI GENTAMICIN RIA KITK810949MRI PROLACTIN RIA KITK802754IMMUNOREACTIVE ESTRIOL RIA KIT

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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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