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)

CHEM 1 CLINICAL ANALYZER (URINE INORGANIC PHOSPHO)

K-Number: K901137 · 1990-04-12

ApplicantTechnicon Instruments Corp.
Decision Date1990-04-12
Product CodeCEO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHEM 1 CLINICAL ANALYZER (URINE INORGANIC PHOSPHO) is the device name listed in this FDA 510(k) record. The listed applicant is Technicon Instruments Corp.. It received FDA 510(k) clearance on 1990-04-12 under 510(k) number K901137. The device is classified under product code CEO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHEM 1 CLINICAL ANALYZER (URINE INORGANIC PHOSPHO)?

CHEM 1 CLINICAL ANALYZER (URINE INORGANIC PHOSPHO) is a medical device that received FDA 510(k) clearance on 1990-04-12. The listed applicant is Technicon Instruments Corp.. The 510(k) number is K901137.

When did CHEM 1 CLINICAL ANALYZER (URINE INORGANIC PHOSPHO) receive FDA 510(k) clearance?

CHEM 1 CLINICAL ANALYZER (URINE INORGANIC PHOSPHO) received FDA 510(k) clearance on 1990-04-12, under 510(k) number K901137.

Who is the listed applicant for CHEM 1 CLINICAL ANALYZER (URINE INORGANIC PHOSPHO)?

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

What is the FDA product code for CHEM 1 CLINICAL ANALYZER (URINE INORGANIC PHOSPHO)?

The FDA product code for CHEM 1 CLINICAL ANALYZER (URINE INORGANIC PHOSPHO) is CEO.

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 Technicon Instruments 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.

K914888TECHNICON CHEM 1(TM) SYST (GEN2 SYST)K914511TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOLK914025TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P)K912616TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTESK912413CHEM-LINK DATA BASE MANAGERK903824DRUG OF ABUSE ANALYSIS SYSTEM FREE RADICAL ASSAY

View all 157 devices →

Related Devices (Code: CEO)

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.

K100263ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTSSeppim S.A.S.K072141S40 CLINICAL ANALYZER, S TEST IP, S TEST UAAlfa Wassermann Diagnostic Technologies, Inc.K041643SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENTBeckman Coulter, Inc.K030015ATAC PAK PHOSPHORUS REAGENTElan DiagnosticsK022312PICCOLO PHOSPHORUS TEST SYSTEMAbaxis, Inc.K013095WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311Wiener Laboratories Saic

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.

↑