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)

APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1

K-Number: K854875 · 1986-01-24

ApplicantPhotec Diagnostics, Inc.
Decision Date1986-01-24
Product CodeDER
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1 is the device name listed in this FDA 510(k) record. The listed applicant is Photec Diagnostics, Inc.. It received FDA 510(k) clearance on 1986-01-24 under 510(k) number K854875. The device is classified under product code DER. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1?

APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1 is a medical device that received FDA 510(k) clearance on 1986-01-24. The listed applicant is Photec Diagnostics, Inc.. The 510(k) number is K854875.

When did APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1 receive FDA 510(k) clearance?

APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1 received FDA 510(k) clearance on 1986-01-24, under 510(k) number K854875.

Who is the listed applicant for APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1?

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

What is the FDA product code for APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1?

The FDA product code for APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1 is DER.

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 Photec Diagnostics, 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.

K897169QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KITK896329D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA.K894057QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL TEST KITK892224D-CHEM(TM) T-UPTAKE TEST KIT FOR T-UPTAKE DETERMINK890027QUIKREAD CHEM. ANALYZER & CHOLES. FOR WHOLE BLOODK890267QUIKREAD CHEM. ANALYZER & CHOLES. FOR SERUM/PLASMA

View all 12 devices →

Related Devices (Code: DER)

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.

K013249TINA-QUANT APOLIPOPROTEIN VER.2Roche Diagnostics Corp.K000921BAYER ADVIA IMS SYSTEM; 200 + 3Bayer Corp.K993354K-ASSAY APO BKamiya Biomedical Co.K993345K-ASSAY APO AIKamiya Biomedical Co.K990594INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1Roche Diagnostics Corp.K983289APOLIPOPROTEIN A1Abbott Laboratories

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.

↑