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)

CLINOVATIVE II DIAGNOSTIC KIT

K-Number: K831837 · 1983-08-01

ApplicantPierce Chemical Co.
Decision Date1983-08-01
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CLINOVATIVE II DIAGNOSTIC KIT is the device name listed in this FDA 510(k) record. The listed applicant is Pierce Chemical Co.. It received FDA 510(k) clearance on 1983-08-01 under 510(k) number K831837. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLINOVATIVE II DIAGNOSTIC KIT?

CLINOVATIVE II DIAGNOSTIC KIT is a medical device that received FDA 510(k) clearance on 1983-08-01. The listed applicant is Pierce Chemical Co.. The 510(k) number is K831837.

When did CLINOVATIVE II DIAGNOSTIC KIT receive FDA 510(k) clearance?

CLINOVATIVE II DIAGNOSTIC KIT received FDA 510(k) clearance on 1983-08-01, under 510(k) number K831837.

Who is the listed applicant for CLINOVATIVE II DIAGNOSTIC KIT?

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

What is the FDA product code for CLINOVATIVE II DIAGNOSTIC KIT?

The FDA product code for CLINOVATIVE II DIAGNOSTIC KIT is LCP.

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 Pierce Chemical Co. 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.

K895661GLYCOTEST II GLYHB ASSAY KITK821360GLYCO-GEL TEST KITK820279GLYCO-GEL TEST KITK781897STAT KIT, MICROPROTEINK780827URIC ACID RAPID STAT KITK780826BILIRUBIN RAPID STAT KIT

View all 10 devices →

Related Devices (Code: LCP)

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.

K221326Nova Allegro HbA1c Assay, Nova Allegro AnalyzerNova Biomedical CorporationK231465Q-Pad Test SystemQurasenseK214117Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 AnalyzerAbbott Diagnostics Technologies ASK192987Aina HbA1c Monitoring System 2Jana Care, Inc.K192369PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test KitIxensor Co, Ltd.K183230OneDraw A1C Test SystemDrawbridge Health, 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.

↑