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)

MICROSOMAL EIA TEST KIT

K-Number: K951364 · 1995-11-20

ApplicantImmunoprobe, Inc.
Decision Date1995-11-20
Product CodeJNL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MICROSOMAL EIA TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Immunoprobe, Inc.. It received FDA 510(k) clearance on 1995-11-20 under 510(k) number K951364. The device is classified under product code JNL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROSOMAL EIA TEST KIT?

MICROSOMAL EIA TEST KIT is a medical device that received FDA 510(k) clearance on 1995-11-20. The listed applicant is Immunoprobe, Inc.. The 510(k) number is K951364.

When did MICROSOMAL EIA TEST KIT receive FDA 510(k) clearance?

MICROSOMAL EIA TEST KIT received FDA 510(k) clearance on 1995-11-20, under 510(k) number K951364.

Who is the listed applicant for MICROSOMAL EIA TEST KIT?

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

What is the FDA product code for MICROSOMAL EIA TEST KIT?

The FDA product code for MICROSOMAL EIA TEST KIT is JNL.

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 Immunoprobe, 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.

K972406ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEMK971393MYCOPLASMA IGG ELISA TEST SYSTEMK961765MPO ELISA TEST SYSTEMK961764PR-3 ELISA TEST SYSTEMK951549EBNA IGG EIA TEST SYSTEMK952523CARDIOLIPIN IGG EIA TEST KIT

View all 14 devices →

Related Devices (Code: JNL)

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.

K250816ADVIA Centaur Anti-Thyroglobulin II (aTgII)Siemens Healthcare Diagnostics, Inc.K240996Access Thyroglobulin Antibody IIBeckman Coulter, Inc.K112933ACCESS THYROGLOBULIN ANITBODYBeckman Coulter, Inc.K072661IMMUNOCAP THYRLOBULIN IMMUNOCAPPhadia US, Inc.K062516ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS)Beckman Coulter, Inc.K971834ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISAMonobind

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.

↑