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FDA 510(k)

FREE T4 MICROWELL EIA, MODEL #7019

K-Number: K982954 · 1998-09-24

ApplicantBiomerica, Inc.
Decision Date1998-09-24
Product CodeCEC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FREE T4 MICROWELL EIA, MODEL #7019 is the device name listed in this FDA 510(k) record. The listed applicant is Biomerica, Inc.. It received FDA 510(k) clearance on 1998-09-24 under 510(k) number K982954. 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 MICROWELL EIA, MODEL #7019?

FREE T4 MICROWELL EIA, MODEL #7019 is a medical device that received FDA 510(k) clearance on 1998-09-24. The listed applicant is Biomerica, Inc.. The 510(k) number is K982954.

When did FREE T4 MICROWELL EIA, MODEL #7019 receive FDA 510(k) clearance?

FREE T4 MICROWELL EIA, MODEL #7019 received FDA 510(k) clearance on 1998-09-24, under 510(k) number K982954.

Who is the listed applicant for FREE T4 MICROWELL EIA, MODEL #7019?

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

What is the FDA product code for FREE T4 MICROWELL EIA, MODEL #7019?

The FDA product code for FREE T4 MICROWELL EIA, MODEL #7019 is CEC.

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Other records listing Biomerica, 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.

K232892Hp Detect™ Stool Antigen ELISAK003856EZ-HCG URINE(PREGNANCY TEST)K962216TSH (MICROWELL) ELISAK960412T-3 MICROWELL EIA MODEL 7013K954256ANTI-TPOK950588T4 MICROWELL EIA (ENZYME IMMUNOASSAY0

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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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