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)

QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT

K-Number: K897169 · 1990-02-23

ApplicantPhotec Diagnostics, Inc.
Decision Date1990-02-23
Product CodeCDT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT 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 1990-02-23 under 510(k) number K897169. The device is classified under product code CDT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT?

QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT is a medical device that received FDA 510(k) clearance on 1990-02-23. The listed applicant is Photec Diagnostics, Inc.. The 510(k) number is K897169.

When did QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT receive FDA 510(k) clearance?

QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT received FDA 510(k) clearance on 1990-02-23, under 510(k) number K897169.

Who is the listed applicant for QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT?

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 QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT?

The FDA product code for QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT is CDT.

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.

K896329D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA.K894057QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL TEST KITK892224D-CHEM(TM) T-UPTAKE TEST KIT FOR T-UPTAKE DETERMINK890267QUIKREAD CHEM. ANALYZER & CHOLES. FOR SERUM/PLASMAK890027QUIKREAD CHEM. ANALYZER & CHOLES. FOR WHOLE BLOODK882307D-CHEM

View all 12 devices →

Related Devices (Code: CDT)

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.

K133067ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENTSiemens Healthcare Diagnostics, Inc.K130332VITROS CHEMISTRY PRODUCTS TRIG SLIDESOrtho-Clinical Diagnostics, Inc.K113830VANTERA CLINICAL ANALYZERLiposcienceK102993ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SLSeppim S.A.S.K063804OLYMPUS TRIGLYCERIDE TEST SYSTEMOlympus America, Inc.K043546DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULEDade Behring, 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.

↑