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)

SRI FERRITIN IMMOENZYMETRIC ASSAY(MAG SOLID-PHASE)

K-Number: K911175 · 1991-04-05

ApplicantSerono-Baker Diagnostics, Inc.
Decision Date1991-04-05
Product CodeDBF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SRI FERRITIN IMMOENZYMETRIC ASSAY(MAG SOLID-PHASE) is the device name listed in this FDA 510(k) record. The listed applicant is Serono-Baker Diagnostics, Inc.. It received FDA 510(k) clearance on 1991-04-05 under 510(k) number K911175. The device is classified under product code DBF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SRI FERRITIN IMMOENZYMETRIC ASSAY(MAG SOLID-PHASE)?

SRI FERRITIN IMMOENZYMETRIC ASSAY(MAG SOLID-PHASE) is a medical device that received FDA 510(k) clearance on 1991-04-05. The listed applicant is Serono-Baker Diagnostics, Inc.. The 510(k) number is K911175.

When did SRI FERRITIN IMMOENZYMETRIC ASSAY(MAG SOLID-PHASE) receive FDA 510(k) clearance?

SRI FERRITIN IMMOENZYMETRIC ASSAY(MAG SOLID-PHASE) received FDA 510(k) clearance on 1991-04-05, under 510(k) number K911175.

Who is the listed applicant for SRI FERRITIN IMMOENZYMETRIC ASSAY(MAG SOLID-PHASE)?

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

What is the FDA product code for SRI FERRITIN IMMOENZYMETRIC ASSAY(MAG SOLID-PHASE)?

The FDA product code for SRI FERRITIN IMMOENZYMETRIC ASSAY(MAG SOLID-PHASE) is DBF.

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 Serono-Baker Diagnostics, 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.

K924257TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAYK915164SRI TESTOSTERONE ENZYME IMMUNOASSAYK914886SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE)K915602SRI DIGOXIN ENZYME IMMUNOASSAYK912937SR1 FREE T4 ENZYME IMMUNOASSAYK914462SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS)

View all 23 devices →

Related Devices (Code: DBF)

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.

K193650LIAISON FerritinDiaSorin, Inc.K191562Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid FactorHORIBA ABX SASK171642Atellica IM Ferritin AssaySiemens Healthcare Diagnostics, Inc.K121232K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATORKamiya Biomedical CompanyK110736ADVIA CHEMISTRY FERRITIN (FRT) METHODSiemens Healthcare Diagnostics, Inc.K100538TINA-QUANT FERRITIN GEN. 4Roche Diagnostics

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.

↑