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)

MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT

K-Number: K971658 · 1997-05-23

ApplicantJay H. Geller
Decision Date1997-05-23
Product CodeDBL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Jay H. Geller. It received FDA 510(k) clearance on 1997-05-23 under 510(k) number K971658. The device is classified under product code DBL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT?

MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT is a medical device that received FDA 510(k) clearance on 1997-05-23. The listed applicant is Jay H. Geller. The 510(k) number is K971658.

When did MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT receive FDA 510(k) clearance?

MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT received FDA 510(k) clearance on 1997-05-23, under 510(k) number K971658.

Who is the listed applicant for MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT?

The FDA 510(k) record lists Jay H. Geller as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT?

The FDA product code for MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT is DBL.

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 Jay H. Geller 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.

K942326HUMAN C5 RID KITSK950015HUMAN PROTEIN C RID TEST KITK943334HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT

Related Devices (Code: DBL)

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.

K180202Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno ConceptsImmuno Concepts, N.A. , Ltd.K980312NOVA LITE ENDOMYSIALInova Diagnostics, Inc.K974169WIELISA ANTI-GBM TEST SYSTEMWieslab ABK971464IMMUNOSCAN ANTI-GBM QUANTITATIVE KITEuro-Diagnostica ABK963525DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KITShield Diagnostics, Ltd.K955431RIT LIVER, KIDNEY, STOMACH IFA KITThe Binding Site, Ltd.

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.

↑