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)

CHOLESTEROL REAGENT

K-Number: K971072 · 1997-06-20

ApplicantDerma Media Lab., Inc.
Decision Date1997-06-20
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHOLESTEROL REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Derma Media Lab., Inc.. It received FDA 510(k) clearance on 1997-06-20 under 510(k) number K971072. The device is classified under product code CHH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHOLESTEROL REAGENT?

CHOLESTEROL REAGENT is a medical device that received FDA 510(k) clearance on 1997-06-20. The listed applicant is Derma Media Lab., Inc.. The 510(k) number is K971072.

When did CHOLESTEROL REAGENT receive FDA 510(k) clearance?

CHOLESTEROL REAGENT received FDA 510(k) clearance on 1997-06-20, under 510(k) number K971072.

Who is the listed applicant for CHOLESTEROL REAGENT?

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

What is the FDA product code for CHOLESTEROL REAGENT?

The FDA product code for CHOLESTEROL REAGENT is CHH.

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 Derma Media Lab., 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.

K971309UREAK970664GLUCOSE REAGENTK971005TRIGLYCERIDESK970867URIC ACID REAGENTK964915MAGNESIUMK964913IRON REAGENT

View all 18 devices →

Related Devices (Code: CHH)

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.

K251091LipidsTruvian HealthK232404CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDESMedicon Hellas S.AK203597Cholesterol2Abbott Ireland Diagnostics DivisionK190490VITROS XT Chemistry Products TRIG-CHOL SlidesOrtho-Clinical Diagnostics, Inc.K181373Extended Lipid Panel AssayLaboratory Corporation of America HoldingsK180504Mission Lipid Panel Monitoring SystemACON Laboratories, 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.

↑