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FDA 510(k)

OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104

K-Number: K070708 · 2007-08-21

ApplicantOlympus Life & Material Science Europa GmbH (Irish
Decision Date2007-08-21
Product CodeCEC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104 is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Life & Material Science Europa GmbH (Irish. It received FDA 510(k) clearance on 2007-08-21 under 510(k) number K070708. 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 OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104?

OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104 is a medical device that received FDA 510(k) clearance on 2007-08-21. The listed applicant is Olympus Life & Material Science Europa GmbH (Irish. The 510(k) number is K070708.

When did OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104 receive FDA 510(k) clearance?

OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104 received FDA 510(k) clearance on 2007-08-21, under 510(k) number K070708.

Who is the listed applicant for OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104?

The FDA 510(k) record lists Olympus Life & Material Science Europa GmbH (Irish as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104?

The FDA product code for OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104 is CEC.

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Other records listing Olympus Life & Material Science Europa GmbH (Irish 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.

K070453OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROLK070835OLYMPUS CK-MB REAGENT

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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