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)

ACE HDL-C REAGENT

K-Number: K971526 · 1997-05-21

ApplicantSchiapparelli Biosystems, Inc.
Decision Date1997-05-21
Product CodeLBS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACE HDL-C REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Schiapparelli Biosystems, Inc.. It received FDA 510(k) clearance on 1997-05-21 under 510(k) number K971526. The device is classified under product code LBS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACE HDL-C REAGENT?

ACE HDL-C REAGENT is a medical device that received FDA 510(k) clearance on 1997-05-21. The listed applicant is Schiapparelli Biosystems, Inc.. The 510(k) number is K971526.

When did ACE HDL-C REAGENT receive FDA 510(k) clearance?

ACE HDL-C REAGENT received FDA 510(k) clearance on 1997-05-21, under 510(k) number K971526.

Who is the listed applicant for ACE HDL-C REAGENT?

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

What is the FDA product code for ACE HDL-C REAGENT?

The FDA product code for ACE HDL-C REAGENT is LBS.

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 Schiapparelli Biosystems, 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.

K991733ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLSK981377ACE T4 REAGENT T4 CALIBRATORSK981375ACE T UPTAKE REAGENT TU CALIBRATORSK973581ACE VALPROIC ACID REAGENT, AED CALIBRATORSK973583ACE THEOPHYLLINE REAGENT, THEO CALIBRATORSK973582ACE PRIMIDONE REAGENT, AED CALIBRATORS

View all 24 devices →

Related Devices (Code: LBS)

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.

K162593HDL-Cholesterol Gen.4Roche Diagnostics Operations (Rdo)K153435Direct HDL Cholesterol (HDL)Randox Laboratories, Ltd.K120609VITROS CHEMISTRY PRODUCTS DHDL SLIDESOrtho-Clinical Diagnostics, Inc.K111516NMR LIPOPROFILE (R) TEST AND NMR PROFILERLiposcience, Inc.K103747ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYSElitechgroup Seppim S.A.S.K111036EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENTMedica Corporation

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.

↑