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)

TIPSEP DIGOXIN RIA

K-Number: K852291 · 1985-06-25

ApplicantNuclear Diagnostics, Inc.
Decision Date1985-06-25
Product CodeDNL
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

TIPSEP DIGOXIN RIA is the device name listed in this FDA 510(k) record. The listed applicant is Nuclear Diagnostics, Inc.. It received FDA 510(k) clearance on 1985-06-25 under 510(k) number K852291. The device is classified under product code DNL. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TIPSEP DIGOXIN RIA?

TIPSEP DIGOXIN RIA is a medical device that received FDA 510(k) clearance on 1985-06-25. The listed applicant is Nuclear Diagnostics, Inc.. The 510(k) number is K852291.

When did TIPSEP DIGOXIN RIA receive FDA 510(k) clearance?

TIPSEP DIGOXIN RIA received FDA 510(k) clearance on 1985-06-25, under 510(k) number K852291.

Who is the listed applicant for TIPSEP DIGOXIN RIA?

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

What is the FDA product code for TIPSEP DIGOXIN RIA?

The FDA product code for TIPSEP DIGOXIN RIA is DNL.

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 Nuclear Diagnostics, 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.

K923917ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAYK932406NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KITK872177TIPSEP-CORTISOL RIA DIAGNOSTIC KITK862312ENZLIPASE, ENZYMATIC LIPASE KITK860472NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESSK861735TIPSEP-TBG ASSAY

View all 22 devices →

Related Devices (Code: DNL)

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.

K852343DIG RADIOIMMUNOASSAY TEST SYSTEMM Nobird, Inc.K811212DIGOXIN (RIA) KITImmuno Assay Corp.K810966DIAGOXIN SQUIBB RADIOIMMUNOASSAY KITE. R. Squibb & Sons, Inc.K802841DIGOXIN RADIOIMMUNOASSAY KITAmerican Diagnostic Corp.K781834TEST SET, 125 I-DIGOXINWien Laboratories, Inc.K781495RIANEN ASSAY SYSTEM, 125I KITNew England Nuclear

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.

↑