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)

RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3

K-Number: K110534 · 2012-01-23

ApplicantRandox Laboratories Limited
Decision Date2012-01-23
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3 is the device name listed in this FDA 510(k) record. The listed applicant is Randox Laboratories Limited. It received FDA 510(k) clearance on 2012-01-23 under 510(k) number K110534. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3?

RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3 is a medical device that received FDA 510(k) clearance on 2012-01-23. The listed applicant is Randox Laboratories Limited. The 510(k) number is K110534.

When did RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3 receive FDA 510(k) clearance?

RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3 received FDA 510(k) clearance on 2012-01-23, under 510(k) number K110534.

Who is the listed applicant for RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3?

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

What is the FDA product code for RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3?

The FDA product code for RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3 is JJY.

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 Randox Laboratories Limited 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.

K250741Evidence MultiSTAT DOA Urine MultiPlexK221550Evidence MultiSTAT DOA Urine MultiPlexK220451Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTATK162275Randox RX Daytona Plus Alkaline Phosphatase (ALP)K161691Direct LDL Cholesterol (LDL)K152343Direct Bilirubin

View all 13 devices →

Related Devices (Code: JJY)

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.

K162530Multichem IA PlusTechno-Path ManufacturingK163629Audit MicroControls Linearity FD Tumor Markers IIAalto Scientific, Ltd.K163015Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPakBio-Rad LaboratoriesK153712VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification KitRadiometer America, Inc.K132227LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAYBio-Rad LaboratoriesK132156RANDOX CSF CONTROLS LEVELS 2 AND 3Randox Laboratories, Ltd.

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.

↑