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)

AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL)

K-Number: K892362 · 1989-05-09

ApplicantAmersham Corp.
Decision Date1989-05-09
Product CodeDBF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL) is the device name listed in this FDA 510(k) record. The listed applicant is Amersham Corp.. It received FDA 510(k) clearance on 1989-05-09 under 510(k) number K892362. 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 AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL)?

AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL) is a medical device that received FDA 510(k) clearance on 1989-05-09. The listed applicant is Amersham Corp.. The 510(k) number is K892362.

When did AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL) receive FDA 510(k) clearance?

AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL) received FDA 510(k) clearance on 1989-05-09, under 510(k) number K892362.

Who is the listed applicant for AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL)?

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

What is the FDA product code for AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL)?

The FDA product code for AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL) 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 Amersham Corp. 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.

K914135AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086K912733AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KITK912766AMERLITE CK-MB ASSAYK904666AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008K902760AMERSHAM TSH CONTROL SERAK901832GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.10415

View all 94 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.

↑