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FDA 510(k)

FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300

K-Number: K020548 · 2002-04-05

ApplicantMonobind
Decision Date2002-04-05
Product CodeCEC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300 is the device name listed in this FDA 510(k) record. The listed applicant is Monobind. It received FDA 510(k) clearance on 2002-04-05 under 510(k) number K020548. 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 FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300?

FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300 is a medical device that received FDA 510(k) clearance on 2002-04-05. The listed applicant is Monobind. The 510(k) number is K020548.

When did FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300 receive FDA 510(k) clearance?

FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300 received FDA 510(k) clearance on 2002-04-05, under 510(k) number K020548.

Who is the listed applicant for FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300?

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

What is the FDA product code for FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300?

The FDA product code for FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300 is CEC.

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Other records listing Monobind 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.

K030860ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300K980088T-UPTAKE MICROPLATE EIAK972720FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)K971834ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISAK971835ANTI-THYROGLOBULIN (TG) MICROPLATE ELISAK971921PROLACTIN (PRL) HORMONE MICROPLATE ELISA

View all 21 devices →

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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