Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TOBRAMYCIN 125I RIA KIT

K-Number: K780182 · 1978-02-13

ApplicantNew England Nuclear
Decision Date1978-02-13
Product CodeDID
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

TOBRAMYCIN 125I RIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is New England Nuclear. It received FDA 510(k) clearance on 1978-02-13 under 510(k) number K780182. The device is classified under product code DID. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOBRAMYCIN 125I RIA KIT?

TOBRAMYCIN 125I RIA KIT is a medical device that received FDA 510(k) clearance on 1978-02-13. The listed applicant is New England Nuclear. The 510(k) number is K780182.

When did TOBRAMYCIN 125I RIA KIT receive FDA 510(k) clearance?

TOBRAMYCIN 125I RIA KIT received FDA 510(k) clearance on 1978-02-13, under 510(k) number K780182.

Who is the listed applicant for TOBRAMYCIN 125I RIA KIT?

The FDA 510(k) record lists New England Nuclear as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOBRAMYCIN 125I RIA KIT?

The FDA product code for TOBRAMYCIN 125I RIA KIT is DID.

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 New England Nuclear 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.

K841478RIANEN CYCLIC-AMP RADIOIMMUNOASSAYK840301RIANEN ESTRIOL RADIOIMMUNOASSAY KITK834038RIANEN FOLLICLE STIMULATING HORMONEK833376RIANEN LUTEINIZING HORMONE RIA KITK831345RIANEN PROLACTIN 125I KITK801245ATOMLIGHT (LIQUID SCINTILLATION SOLUTION

View all 18 devices →

Related Devices (Code: DID)

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.

K820773EMIT-ST URINE COCAINE METABOLITE ASSAYSyva Co.K802038PHENYTOIN REAGENT TEST KITBeckman Instruments, Inc.K780950BIO-MONITOR TOBRAMYCINMonitor Science Corp.K780048AMINOGLYCOSIDE TEST SYSTEMNichols Institute Diagnostics

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.

↑