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)

LIQUICHEK HOMOCYSTEINE CONTROL, CAT #644

K-Number: K984071 · 1998-12-03

ApplicantBio-Rad
Decision Date1998-12-03
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LIQUICHEK HOMOCYSTEINE CONTROL, CAT #644 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1998-12-03 under 510(k) number K984071. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIQUICHEK HOMOCYSTEINE CONTROL, CAT #644?

LIQUICHEK HOMOCYSTEINE CONTROL, CAT #644 is a medical device that received FDA 510(k) clearance on 1998-12-03. The listed applicant is Bio-Rad. The 510(k) number is K984071.

When did LIQUICHEK HOMOCYSTEINE CONTROL, CAT #644 receive FDA 510(k) clearance?

LIQUICHEK HOMOCYSTEINE CONTROL, CAT #644 received FDA 510(k) clearance on 1998-12-03, under 510(k) number K984071.

Who is the listed applicant for LIQUICHEK HOMOCYSTEINE CONTROL, CAT #644?

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

What is the FDA product code for LIQUICHEK HOMOCYSTEINE CONTROL, CAT #644?

The FDA product code for LIQUICHEK HOMOCYSTEINE CONTROL, CAT #644 is JJX.

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 Bio-Rad 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.

K171061MRSASelect IIK122187VRESELECT CULTURE MEDIUMK103684VRESELECT CULTURE MEDIUMK093678PLATELIA ASPERGILLUS EIA MODEL 62793K100589MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENSK081362PLATELIA LYME IGM

View all 319 devices →

Related Devices (Code: JJX)

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.

K170678Beta-CrossLaps CalCheck 5Roche DiagnosticsK162173Elecsys CYFRA 21-1 CalCheck 5Roche DiagnosticsK162514Multichem A1cTechnopath ManufacturingK161874Audit MicroControls Linearity DROP LQ Blood GlucoseAalto Scientific, Ltd.K161526LIAISON CMV IgM Serum Control SetDiaSorin, Inc.K161522LIAISON EBV IgM Serum Control SetDiaSorin, 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.

↑