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FDA 510(k)

MODIFIED FREE T4 RADIOIMMUNOASSAY KIT

K-Number: K884753 · 1989-02-27

ApplicantAdvanced Magnetics, Inc.
Decision Date1989-02-27
Product CodeCEC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODIFIED FREE T4 RADIOIMMUNOASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Magnetics, Inc.. It received FDA 510(k) clearance on 1989-02-27 under 510(k) number K884753. 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 MODIFIED FREE T4 RADIOIMMUNOASSAY KIT?

MODIFIED FREE T4 RADIOIMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1989-02-27. The listed applicant is Advanced Magnetics, Inc.. The 510(k) number is K884753.

When did MODIFIED FREE T4 RADIOIMMUNOASSAY KIT receive FDA 510(k) clearance?

MODIFIED FREE T4 RADIOIMMUNOASSAY KIT received FDA 510(k) clearance on 1989-02-27, under 510(k) number K884753.

Who is the listed applicant for MODIFIED FREE T4 RADIOIMMUNOASSAY KIT?

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

What is the FDA product code for MODIFIED FREE T4 RADIOIMMUNOASSAY KIT?

The FDA product code for MODIFIED FREE T4 RADIOIMMUNOASSAY KIT is CEC.

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.

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Other records listing Advanced Magnetics, 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.

K902748SEROZYME FREE T3 IMMUNOASSAYK900060FREE T4 IMMUNOASSAY KITK894200FREE T3 RADIOIMMUNOASSAY KIT

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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