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 L KIT, MODEL B022-112

K-Number: K070889 · 2008-04-14

ApplicantWallac OY
Decision Date2008-04-14
Product CodeCGZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112 is the device name listed in this FDA 510(k) record. The listed applicant is Wallac OY. It received FDA 510(k) clearance on 2008-04-14 under 510(k) number K070889. 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 L KIT, MODEL B022-112?

AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112 is a medical device that received FDA 510(k) clearance on 2008-04-14. The listed applicant is Wallac OY. The 510(k) number is K070889.

When did AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112 receive FDA 510(k) clearance?

AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112 received FDA 510(k) clearance on 2008-04-14, under 510(k) number K070889.

Who is the listed applicant for AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112?

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 L KIT, MODEL B022-112?

The FDA product code for AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112 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 3029-110BK050709RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367K050960MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT

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.K070531ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZERThermo Fisher ScientificK060108COBAS INTEGRA CHLORIDE ELCTRODE GEN.2Roche Diagnostics 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.

↑