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)

SPINSEP-FE59

K-Number: K790133 · 1979-03-02

ApplicantNuclear Diagnostics, Inc.
Decision Date1979-03-02
Product CodeJQG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SPINSEP-FE59 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 1979-03-02 under 510(k) number K790133. The device is classified under product code JQG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPINSEP-FE59?

SPINSEP-FE59 is a medical device that received FDA 510(k) clearance on 1979-03-02. The listed applicant is Nuclear Diagnostics, Inc.. The 510(k) number is K790133.

When did SPINSEP-FE59 receive FDA 510(k) clearance?

SPINSEP-FE59 received FDA 510(k) clearance on 1979-03-02, under 510(k) number K790133.

Who is the listed applicant for SPINSEP-FE59?

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 SPINSEP-FE59?

The FDA product code for SPINSEP-FE59 is JQG.

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: JQG)

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.

K811954COMBO-FER IRON DIAGNOSTICImmuno Assay Corp.K800710FERRITIRON KIT CAT. #RP-1100Ria Products, Inc.K800868FERRO-QUANT TM FE 59 TEST KITMallinckrodt Critical CareK780412TOTAL IRON BINDING CAPACITYDiagnostic Corp. of America

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.

↑