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)

GILCHEM ALP REAGENT

K-Number: K812912 · 1981-11-02

ApplicantGilford Diagnostics
Decision Date1981-11-02
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GILCHEM ALP REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Gilford Diagnostics. It received FDA 510(k) clearance on 1981-11-02 under 510(k) number K812912. The device is classified under product code CJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GILCHEM ALP REAGENT?

GILCHEM ALP REAGENT is a medical device that received FDA 510(k) clearance on 1981-11-02. The listed applicant is Gilford Diagnostics. The 510(k) number is K812912.

When did GILCHEM ALP REAGENT receive FDA 510(k) clearance?

GILCHEM ALP REAGENT received FDA 510(k) clearance on 1981-11-02, under 510(k) number K812912.

Who is the listed applicant for GILCHEM ALP REAGENT?

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

What is the FDA product code for GILCHEM ALP REAGENT?

The FDA product code for GILCHEM ALP REAGENT is CJE.

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 Gilford Diagnostics 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.

K832094BILIRUBIN CALIBRATORS & CONTROLK831843GILCHEM TOTAL BILIRUBIN REAGENTK831844DIRECT BILIRUBIN REAGENTK823709TRIGLYCERIDE REAGENT (UV)K822739AHBDK822334BILIRUBIN CALIBRATORS

View all 50 devices →

Related Devices (Code: CJE)

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.

K251074Tru Liver Health Test PanelTruvian HealthK240468Alkaline PhosphataseAbbott Laboratories Diagnostics DivisionK223317Alkaline Phosphatase2Abbott Ireland Diagnostics DivisionK191245Yumizen C1200 ALP, Yumizen C1200 AlbuminHORIBA ABX SASK171971Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry AnalyzerLite-On Technology Corp. H.S.P.B.K171080ALP IFCC Gen.2Roche Diagnostics Operations (Rdo)

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.

↑