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)

PSI INORGANIC PHOSPHORUS

K-Number: K822470 · 1982-09-14

ApplicantPointe Scientific, Inc.,
Decision Date1982-09-14
Product CodeCEO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PSI INORGANIC PHOSPHORUS is the device name listed in this FDA 510(k) record. The listed applicant is Pointe Scientific, Inc.,. It received FDA 510(k) clearance on 1982-09-14 under 510(k) number K822470. 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 PSI INORGANIC PHOSPHORUS?

PSI INORGANIC PHOSPHORUS is a medical device that received FDA 510(k) clearance on 1982-09-14. The listed applicant is Pointe Scientific, Inc.,. The 510(k) number is K822470.

When did PSI INORGANIC PHOSPHORUS receive FDA 510(k) clearance?

PSI INORGANIC PHOSPHORUS received FDA 510(k) clearance on 1982-09-14, under 510(k) number K822470.

Who is the listed applicant for PSI INORGANIC PHOSPHORUS?

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

What is the FDA product code for PSI INORGANIC PHOSPHORUS?

The FDA product code for PSI INORGANIC PHOSPHORUS 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 Pointe Scientific, 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.

K070757MICROPROTEIN REAGENT SETK062118POINTE 360K070251CARBON DIOXIDE LIQUID STABLE REAGENTK070207MULTI-ANALYTE CHEMISTRY CALIBRATORK070504AMMONIA/ALCOHOL CONTROL SETK061377APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS

View all 74 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.

↑