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FDA 510(k)

QUIKREAD CHEM. ANALYZER & CHOLES. FOR WHOLE BLOOD

K-Number: K890027 · 1989-04-26

ApplicantPhotec Diagnostics, Inc.
Decision Date1989-04-26
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUIKREAD CHEM. ANALYZER & CHOLES. FOR WHOLE BLOOD 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 1989-04-26 under 510(k) number K890027. The device is classified under product code CHH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUIKREAD CHEM. ANALYZER & CHOLES. FOR WHOLE BLOOD?

QUIKREAD CHEM. ANALYZER & CHOLES. FOR WHOLE BLOOD is a medical device that received FDA 510(k) clearance on 1989-04-26. The listed applicant is Photec Diagnostics, Inc.. The 510(k) number is K890027.

When did QUIKREAD CHEM. ANALYZER & CHOLES. FOR WHOLE BLOOD receive FDA 510(k) clearance?

QUIKREAD CHEM. ANALYZER & CHOLES. FOR WHOLE BLOOD received FDA 510(k) clearance on 1989-04-26, under 510(k) number K890027.

Who is the listed applicant for QUIKREAD CHEM. ANALYZER & CHOLES. FOR WHOLE BLOOD?

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 CHEM. ANALYZER & CHOLES. FOR WHOLE BLOOD?

The FDA product code for QUIKREAD CHEM. ANALYZER & CHOLES. FOR WHOLE BLOOD is CHH.

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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.K894057QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL TEST KITK892224D-CHEM(TM) T-UPTAKE TEST KIT FOR T-UPTAKE DETERMINK890267QUIKREAD CHEM. ANALYZER & CHOLES. FOR SERUM/PLASMAK882307D-CHEM

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Related Devices (Code: CHH)

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.

K251091LipidsTruvian HealthK232404CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDESMedicon Hellas S.AK203597Cholesterol2Abbott Ireland Diagnostics DivisionK190490VITROS XT Chemistry Products TRIG-CHOL SlidesOrtho-Clinical Diagnostics, Inc.K181373Extended Lipid Panel AssayLaboratory Corporation of America HoldingsK180504Mission Lipid Panel Monitoring SystemACON 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.

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