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)

AUTODELFIA NEONATAL IRT KIT, MODEL B005-112

K-Number: K003668 · 2001-02-12

ApplicantWallac OY
Decision Date2001-02-12
Product CodeCGZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AUTODELFIA NEONATAL IRT KIT, MODEL B005-112 is the device name listed in this FDA 510(k) record. The listed applicant is Wallac OY. It received FDA 510(k) clearance on 2001-02-12 under 510(k) number K003668. The device is classified under product code CGZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTODELFIA NEONATAL IRT KIT, MODEL B005-112?

AUTODELFIA NEONATAL IRT KIT, MODEL B005-112 is a medical device that received FDA 510(k) clearance on 2001-02-12. The listed applicant is Wallac OY. The 510(k) number is K003668.

When did AUTODELFIA NEONATAL IRT KIT, MODEL B005-112 receive FDA 510(k) clearance?

AUTODELFIA NEONATAL IRT KIT, MODEL B005-112 received FDA 510(k) clearance on 2001-02-12, under 510(k) number K003668.

Who is the listed applicant for AUTODELFIA NEONATAL IRT KIT, MODEL B005-112?

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

What is the FDA product code for AUTODELFIA NEONATAL IRT KIT, MODEL B005-112?

The FDA product code for AUTODELFIA NEONATAL IRT KIT, MODEL B005-112 is CGZ.

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 Wallac OY 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.

K131284GSP NEONATAL BIOTINIDASE KITK100682GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001UK081922AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KITK071649NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110BK070889AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112K050709RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367

View all 21 devices →

Related Devices (Code: CGZ)

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.

K182072VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU SlidesOrtho-Clinical Diagnostics, Inc.K170320Alinity c ICT Sample DiluentAbbott LaboratoriesK162020VITROS Chemistry Products Cl- SlidesOrtho Clinical DiagnosticsK082099VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CI-DT SLIDES:131 4905Ortho-Clinical Diagnostics, Inc.K070889AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112Wallac OYK070531ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZERThermo Fisher Scientific

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.

↑