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)

IONIZED CALCIUM AND BLOOD PH TESTCARDS

K-Number: K860639 · 1986-04-21

ApplicantIlex Corp.
Decision Date1986-04-21
Product CodeJFP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IONIZED CALCIUM AND BLOOD PH TESTCARDS is the device name listed in this FDA 510(k) record. The listed applicant is Ilex Corp.. It received FDA 510(k) clearance on 1986-04-21 under 510(k) number K860639. The device is classified under product code JFP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IONIZED CALCIUM AND BLOOD PH TESTCARDS?

IONIZED CALCIUM AND BLOOD PH TESTCARDS is a medical device that received FDA 510(k) clearance on 1986-04-21. The listed applicant is Ilex Corp.. The 510(k) number is K860639.

When did IONIZED CALCIUM AND BLOOD PH TESTCARDS receive FDA 510(k) clearance?

IONIZED CALCIUM AND BLOOD PH TESTCARDS received FDA 510(k) clearance on 1986-04-21, under 510(k) number K860639.

Who is the listed applicant for IONIZED CALCIUM AND BLOOD PH TESTCARDS?

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

What is the FDA product code for IONIZED CALCIUM AND BLOOD PH TESTCARDS?

The FDA product code for IONIZED CALCIUM AND BLOOD PH TESTCARDS is JFP.

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 Ilex 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.

K860543BLOOD UREA NITROGEN (BUN) TESTCARDK853068ILEX PROMPT CLINICAL CHEMISTRY ANALYER

Related Devices (Code: JFP)

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.

K230300i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K191360i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K191626Stat Profile Prime ES Comp Plus Analyzer SystemNova Biomedical CorporationK152327EasyLyte Na/K/Cl/Ca AnalyzerMedica CorporationK984299AVL OPTI CRITICAL CARE ANALYZERAvl Scientific Corp.K972673AVL 9181 ELECTROLYTE ANALYZERAvl Scientific Corp.

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.

↑