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)

TEST, FERROZINE IRON & IRON BINDING

K-Number: K770748 · 1977-06-01

ApplicantHycel, Inc.
Decision Date1977-06-01
Product CodeJMO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TEST, FERROZINE IRON & IRON BINDING is the device name listed in this FDA 510(k) record. The listed applicant is Hycel, Inc.. It received FDA 510(k) clearance on 1977-06-01 under 510(k) number K770748. The device is classified under product code JMO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEST, FERROZINE IRON & IRON BINDING?

TEST, FERROZINE IRON & IRON BINDING is a medical device that received FDA 510(k) clearance on 1977-06-01. The listed applicant is Hycel, Inc.. The 510(k) number is K770748.

When did TEST, FERROZINE IRON & IRON BINDING receive FDA 510(k) clearance?

TEST, FERROZINE IRON & IRON BINDING received FDA 510(k) clearance on 1977-06-01, under 510(k) number K770748.

Who is the listed applicant for TEST, FERROZINE IRON & IRON BINDING?

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

What is the FDA product code for TEST, FERROZINE IRON & IRON BINDING?

The FDA product code for TEST, FERROZINE IRON & IRON BINDING is JMO.

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 Hycel, 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.

K802422HYCEL TRIGYCERIDE II TESTK790335HYCEL MK782116KETOSTEROID TEST, HYCEL-17K782176HYCEL LDH-INT TESTK782100HYCEL COUNTER 333K782102HYCEL COUNTER 211

View all 22 devices →

Related Devices (Code: JMO)

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.

K113438ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K061464VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668Ortho-Clinical Diagnostics, Inc.K052867VITROS CHEMISTRY PRODUCTS DTIBC REAGENTOrtho-Clinical Diagnostics, Inc.K041793OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524Olympus America, Inc.K013102WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002Wiener Laboratories SaicK012340BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC)Bayer 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.

↑