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)

SYNERMED CHOLESTEROL REAGENT KIT

K-Number: K903015 · 1990-10-01

ApplicantSynermed, Inc.
Decision Date1990-10-01
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYNERMED CHOLESTEROL REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Synermed, Inc.. It received FDA 510(k) clearance on 1990-10-01 under 510(k) number K903015. 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 SYNERMED CHOLESTEROL REAGENT KIT?

SYNERMED CHOLESTEROL REAGENT KIT is a medical device that received FDA 510(k) clearance on 1990-10-01. The listed applicant is Synermed, Inc.. The 510(k) number is K903015.

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

SYNERMED CHOLESTEROL REAGENT KIT received FDA 510(k) clearance on 1990-10-01, under 510(k) number K903015.

Who is the listed applicant for SYNERMED CHOLESTEROL REAGENT KIT?

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

What is the FDA product code for SYNERMED CHOLESTEROL REAGENT KIT?

The FDA product code for SYNERMED CHOLESTEROL REAGENT KIT 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 Synermed, 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.

K973109SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KITK972716SYNERMED TOTAL BILIRUBIN REAGENT KITK971491SYNERMED IR 200 CHEMISTRY ANALYZERK962479SYNERMED ISE REAGENTSK963939SYNERMED DIRECT BILIRUBIN REAGENT KITK960793SYNERMED ENZYMATIC CO2 REAGENT KIT

View all 45 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.

↑