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)

IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15

K-Number: K994035 · 2000-02-01

ApplicantDiagnostic Chemicals , Ltd.
Decision Date2000-02-01
Product CodeJIR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals , Ltd.. It received FDA 510(k) clearance on 2000-02-01 under 510(k) number K994035. The device is classified under product code JIR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15?

IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15 is a medical device that received FDA 510(k) clearance on 2000-02-01. The listed applicant is Diagnostic Chemicals , Ltd.. The 510(k) number is K994035.

When did IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15 receive FDA 510(k) clearance?

IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15 received FDA 510(k) clearance on 2000-02-01, under 510(k) number K994035.

Who is the listed applicant for IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15?

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

What is the FDA product code for IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15?

The FDA product code for IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15 is JIR.

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 Diagnostic Chemicals , 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.

K070383ENZYMATIC CREATININE ASSAY (265 SERIES)K063208MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7K060139CRP-ADVANCE ASSAY, MODELS 250-20, 250-25K060140CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250K051757CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91K051191DCL MICROALBUMIN ASSAY, MODEL 252-20

View all 66 devices →

Related Devices (Code: JIR)

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.

K222921Minuteful-kidney testHealthy.Io, Ltd.K210069Minuteful - kidney testHealthy.Io, Ltd.K061419TECO MICROALBUMIN 2-1 COMBO STRIPSTeco DiagnosticsK022538IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25Diagnostic Chemicals, Ltd. (Usa)K001810URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTINGFlexsite Diagnostics, Inc.K992257NEW MULTIPLES REAGENT STRIPSBayer Corp.

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.

↑