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FDA 510(k)

KALLESTAD ANTISERA TO TOBRAMYCIN

K-Number: K812415 · 1981-09-09

ApplicantKallestad Laboratories, Inc.
Decision Date1981-09-09
Product CodeKLB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

KALLESTAD ANTISERA TO TOBRAMYCIN is the device name listed in this FDA 510(k) record. The listed applicant is Kallestad Laboratories, Inc.. It received FDA 510(k) clearance on 1981-09-09 under 510(k) number K812415. 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 KALLESTAD ANTISERA TO TOBRAMYCIN?

KALLESTAD ANTISERA TO TOBRAMYCIN is a medical device that received FDA 510(k) clearance on 1981-09-09. The listed applicant is Kallestad Laboratories, Inc.. The 510(k) number is K812415.

When did KALLESTAD ANTISERA TO TOBRAMYCIN receive FDA 510(k) clearance?

KALLESTAD ANTISERA TO TOBRAMYCIN received FDA 510(k) clearance on 1981-09-09, under 510(k) number K812415.

Who is the listed applicant for KALLESTAD ANTISERA TO TOBRAMYCIN?

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

What is the FDA product code for KALLESTAD ANTISERA TO TOBRAMYCIN?

The FDA product code for KALLESTAD ANTISERA TO TOBRAMYCIN is KLB.

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Other records listing Kallestad Laboratories, 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.

K863681PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEMK862917PATHFINDER ROTAVIRUS CHEMILUMINESCENTK863682PATHFINDER(TM) SPECIMEN COLLECTION KITK862743PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUSK862313KALLESTAD SM/RNP TEST REAGENTK862710KALLESTAD SSA/SSB ENA TEST REAGENTS

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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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