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)

TOTAL LIPID REAGENT SET

K-Number: K820500 · 1982-03-11

ApplicantAnco Medical Reagents & Assoc.
Decision Date1982-03-11
Product CodeCFD
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TOTAL LIPID REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Anco Medical Reagents & Assoc.. It received FDA 510(k) clearance on 1982-03-11 under 510(k) number K820500. The device is classified under product code CFD. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOTAL LIPID REAGENT SET?

TOTAL LIPID REAGENT SET is a medical device that received FDA 510(k) clearance on 1982-03-11. The listed applicant is Anco Medical Reagents & Assoc.. The 510(k) number is K820500.

When did TOTAL LIPID REAGENT SET receive FDA 510(k) clearance?

TOTAL LIPID REAGENT SET received FDA 510(k) clearance on 1982-03-11, under 510(k) number K820500.

Who is the listed applicant for TOTAL LIPID REAGENT SET?

The FDA 510(k) record lists Anco Medical Reagents & Assoc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOTAL LIPID REAGENT SET?

The FDA product code for TOTAL LIPID REAGENT SET is CFD.

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 Anco Medical Reagents & Assoc. 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.

K842440SICKLE CELL STAT A/S HETEROZYGOUS-ERYTHK831871SICKLE-HEME A/S CONTROLS & A/A CONTROLK821658HEMOGLOBIN REAGENTK821526ACID PHOSPHATASE REAGENT SETK821102MEGNESIUM REAGENT KITK820951ENZYMATIC CHOLESTEROL KIT

View all 26 devices →

Related Devices (Code: CFD)

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.

K863073TOTAL LIPIDSJ. D. Assoc.K860112TOTAL LIPIDS REAGENT SETTechnostics Intl.K813469LIPID PROFILEBio-Analytics 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.

↑