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FDA 510(k)

QUIKREAD CHEM. ANALYZER & CHOLES. FOR SERUM/PLASMA

K-Number: K890267 · 1989-04-26

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

Device Summary

QUIKREAD CHEM. ANALYZER & CHOLES. FOR SERUM/PLASMA 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 K890267. 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 SERUM/PLASMA?

QUIKREAD CHEM. ANALYZER & CHOLES. FOR SERUM/PLASMA 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 K890267.

When did QUIKREAD CHEM. ANALYZER & CHOLES. FOR SERUM/PLASMA receive FDA 510(k) clearance?

QUIKREAD CHEM. ANALYZER & CHOLES. FOR SERUM/PLASMA received FDA 510(k) clearance on 1989-04-26, under 510(k) number K890267.

Who is the listed applicant for QUIKREAD CHEM. ANALYZER & CHOLES. FOR SERUM/PLASMA?

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 SERUM/PLASMA?

The FDA product code for QUIKREAD CHEM. ANALYZER & CHOLES. FOR SERUM/PLASMA 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 DETERMINK890027QUIKREAD CHEM. ANALYZER & CHOLES. FOR WHOLE BLOODK882307D-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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