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FDA 510(k)

GAMMA STICK 125-1 TOBRAMYCIN RIA KIT

K-Number: K810011 · 1981-01-28

ApplicantAlpha Gamma Laboratory
Decision Date1981-01-28
Product CodeKLB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

GAMMA STICK 125-1 TOBRAMYCIN RIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Alpha Gamma Laboratory. It received FDA 510(k) clearance on 1981-01-28 under 510(k) number K810011. 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 GAMMA STICK 125-1 TOBRAMYCIN RIA KIT?

GAMMA STICK 125-1 TOBRAMYCIN RIA KIT is a medical device that received FDA 510(k) clearance on 1981-01-28. The listed applicant is Alpha Gamma Laboratory. The 510(k) number is K810011.

When did GAMMA STICK 125-1 TOBRAMYCIN RIA KIT receive FDA 510(k) clearance?

GAMMA STICK 125-1 TOBRAMYCIN RIA KIT received FDA 510(k) clearance on 1981-01-28, under 510(k) number K810011.

Who is the listed applicant for GAMMA STICK 125-1 TOBRAMYCIN RIA KIT?

The FDA 510(k) record lists Alpha Gamma Laboratory as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GAMMA STICK 125-1 TOBRAMYCIN RIA KIT?

The FDA product code for GAMMA STICK 125-1 TOBRAMYCIN RIA KIT is KLB.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Alpha Gamma Laboratory 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.

K800537GAMMA STICK GENTAMICIN RIA KITK800538GAMMA STICK CORTISOL RIA KIT/STICK KITK780492GAMMA STIK 125I T3 UPTAKE KIT

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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