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)

TOTAL PROTEIN REAGENT FOR DEMAND ANALYZER

K-Number: K844331 · 1985-01-03

ApplicantAdvanced Biomedical Methods, Inc.
Decision Date1985-01-03
Product CodeCEK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TOTAL PROTEIN REAGENT FOR DEMAND ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Biomedical Methods, Inc.. It received FDA 510(k) clearance on 1985-01-03 under 510(k) number K844331. The device is classified under product code CEK. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOTAL PROTEIN REAGENT FOR DEMAND ANALYZER?

TOTAL PROTEIN REAGENT FOR DEMAND ANALYZER is a medical device that received FDA 510(k) clearance on 1985-01-03. The listed applicant is Advanced Biomedical Methods, Inc.. The 510(k) number is K844331.

When did TOTAL PROTEIN REAGENT FOR DEMAND ANALYZER receive FDA 510(k) clearance?

TOTAL PROTEIN REAGENT FOR DEMAND ANALYZER received FDA 510(k) clearance on 1985-01-03, under 510(k) number K844331.

Who is the listed applicant for TOTAL PROTEIN REAGENT FOR DEMAND ANALYZER?

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

What is the FDA product code for TOTAL PROTEIN REAGENT FOR DEMAND ANALYZER?

The FDA product code for TOTAL PROTEIN REAGENT FOR DEMAND ANALYZER is CEK.

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 Advanced Biomedical Methods, 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.

K945353CLARIT(TM)K880949SINGLE REAGENT CALCIUM FOR DEMAND ANALYZERK864866RESUBMISSION OF THE KLEERZIT REAGENTK852784ALKALINE PHOSPHATASEK852783SGOT/ALT REAGENTK852027GGTP REAGENT/SERUM IRON/SALICYLATE DEMAND ANALYZER

View all 21 devices →

Related Devices (Code: CEK)

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.

K992846HICHEM TOTAL PROTEIN REAGENTElan Holdings, Inc.K973108TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50Diagnostic Chemicals , Ltd.K980042CARESIDE TOTAL PROTEINExigent Diagnostics, Inc.K971524TOTAL PROTEIN OR TPCarolina Liquid Chemistries Corp.K961864CSF/URINE TOTAL PROTEINTeco DiagnosticsK955905STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAYSolarcare Technologies Corp,Inc.

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.

↑