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FDA 510(k)

FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM

K-Number: K971141 · 1997-04-28

ApplicantDade Chemistry Systems, Inc.
Decision Date1997-04-28
Product CodeCEC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dade Chemistry Systems, Inc.. It received FDA 510(k) clearance on 1997-04-28 under 510(k) number K971141. The device is classified under product code CEC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM?

FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM is a medical device that received FDA 510(k) clearance on 1997-04-28. The listed applicant is Dade Chemistry Systems, Inc.. The 510(k) number is K971141.

When did FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM receive FDA 510(k) clearance?

FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM received FDA 510(k) clearance on 1997-04-28, under 510(k) number K971141.

Who is the listed applicant for FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM?

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

What is the FDA product code for FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM?

The FDA product code for FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM is CEC.

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Other records listing Dade Chemistry Systems, 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.

K973650TROPONIN (TROP) METHODK973100PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATORK973099PROSTATE SPECIFIC ANTIGEN CONTROLK973101PROSTATE SPECIFIC ANTIGEN METHODK970387HUMAN CHORIONIC GONADOTROPIN METHODK970336MMB CALIBRATOR

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Related Devices (Code: CEC)

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.

K240273Access Free T4Beckman Coulter, Inc.K220456Elecsys FT4 IVRoche DiagnosticsK182423MAGLUMI 2000 FT4Shenzhen New Industries Biomedical Engineering Co., Ltd.K181233Elecsys FT4 IIIRoche DiagnosticsK173122Abbott Architect Free T4Abbott LaboratoriesK152422FREND™ Free T4 Test SystemNanoentek USA, 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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