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)

AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM

K-Number: K030775 · 2003-05-12

ApplicantImmuno Concepts, N.A. , Ltd.
Decision Date2003-05-12
Product CodeLKJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM is the device name listed in this FDA 510(k) record. The listed applicant is Immuno Concepts, N.A. , Ltd.. It received FDA 510(k) clearance on 2003-05-12 under 510(k) number K030775. The device is classified under product code LKJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM?

AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM is a medical device that received FDA 510(k) clearance on 2003-05-12. The listed applicant is Immuno Concepts, N.A. , Ltd.. The 510(k) number is K030775.

When did AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM receive FDA 510(k) clearance?

AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM received FDA 510(k) clearance on 2003-05-12, under 510(k) number K030775.

Who is the listed applicant for AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM?

The FDA 510(k) record lists Immuno Concepts, N.A. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM?

The FDA product code for AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM is LKJ.

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 Immuno Concepts, N.A. , Ltd. 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.

K203599Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test SystemK180202Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno ConceptsK160265Image Navigator by Immuno Concepts

Related Devices (Code: LKJ)

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.

K210902EliA Ro52, EliA Ro60Phadia ABK113610ANA-SCREEN WITH MDSSBio-Rad LaboratoriesK082759ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAYPhadia US, Inc.K081104AESKULISA ANA HEP-2, REF 30-7115USAesku DiagnosticsK041658BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200Bio-Rad Laboratories, Inc.K042416ATHENA MULTI-LYTE ANA-II TEST SYSTEMZeus Scientific, Inc.

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.

↑