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FDA 510(k)

TOBRAMYCIN REAGENT

K-Number: K832763 · 1984-03-23

ApplicantBiosan Laboratories, Inc.
Decision Date1984-03-23
Product CodeKLB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

TOBRAMYCIN REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Biosan Laboratories, Inc.. It received FDA 510(k) clearance on 1984-03-23 under 510(k) number K832763. 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 TOBRAMYCIN REAGENT?

TOBRAMYCIN REAGENT is a medical device that received FDA 510(k) clearance on 1984-03-23. The listed applicant is Biosan Laboratories, Inc.. The 510(k) number is K832763.

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

TOBRAMYCIN REAGENT received FDA 510(k) clearance on 1984-03-23, under 510(k) number K832763.

Who is the listed applicant for TOBRAMYCIN REAGENT?

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

What is the FDA product code for TOBRAMYCIN REAGENT?

The FDA product code for TOBRAMYCIN REAGENT is KLB.

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Other records listing Biosan 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.

K860642PHOTRON VISUAL FIELD ANALYZERK853812PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION)K833193RADIOIMMUNOASSAY, THYROID STIMU. HORMONEK834023BIO-SCIENCE LABORATORIES T4 REAGENTK833318NORMAL GOAT SERUMK833191ABNORMAL URINE CONTROL

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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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