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FDA 510(k)

QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL TEST KIT

K-Number: K894057 · 1989-08-31

ApplicantPhotec Diagnostics, Inc.
Decision Date1989-08-31
Product CodeLBS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL 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 1989-08-31 under 510(k) number K894057. 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 QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL TEST KIT?

QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL TEST KIT is a medical device that received FDA 510(k) clearance on 1989-08-31. The listed applicant is Photec Diagnostics, Inc.. The 510(k) number is K894057.

When did QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL TEST KIT receive FDA 510(k) clearance?

QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL TEST KIT received FDA 510(k) clearance on 1989-08-31, under 510(k) number K894057.

Who is the listed applicant for QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL 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 WHOLE BLOOD HDL-CHOLESTEROL TEST KIT?

The FDA product code for QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL TEST KIT is LBS.

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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.K892224D-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: 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.

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