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FDA 510(k)

GAMMA STICK GENTAMICIN RIA KIT

K-Number: K800537 · 1980-04-24

ApplicantAlpha Gamma Laboratory
Decision Date1980-04-24
Product CodeDJB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

GAMMA STICK GENTAMICIN 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 1980-04-24 under 510(k) number K800537. The device is classified under product code DJB. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAMMA STICK GENTAMICIN RIA KIT?

GAMMA STICK GENTAMICIN RIA KIT is a medical device that received FDA 510(k) clearance on 1980-04-24. The listed applicant is Alpha Gamma Laboratory. The 510(k) number is K800537.

When did GAMMA STICK GENTAMICIN RIA KIT receive FDA 510(k) clearance?

GAMMA STICK GENTAMICIN RIA KIT received FDA 510(k) clearance on 1980-04-24, under 510(k) number K800537.

Who is the listed applicant for GAMMA STICK GENTAMICIN 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 GENTAMICIN RIA KIT?

The FDA product code for GAMMA STICK GENTAMICIN RIA KIT is DJB.

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.

K810011GAMMA STICK 125-1 TOBRAMYCIN RIA KITK800538GAMMA STICK CORTISOL RIA KIT/STICK KITK780492GAMMA STIK 125I T3 UPTAKE KIT

Related Devices (Code: DJB)

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.

K832792AMES TDA SISOMICIN TEST-CONTROL SERUMMiles Laboratories, Inc.K831210GENTAMICIN TEST PACK-ACAE.I. Dupont DE Nemours & Co., Inc.K821669AMES TDA GENTAMICIN TESTMiles Laboratories, Inc.K812394MRI GENTAMICIN RIA KITMicroanalytic Research, Inc.K811844COAT-A-COUNT GENTAMICIN RIA KITDiagnostic Products Corp.K791770QUANTIMUNE GENTAMICIN RIA GENTAMICINBio-Rad

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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