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FDA 510(k)

BIOSTRIDE FREE T4 EIA TEST KIT

K-Number: K981243 · 1998-06-29

ApplicantBiostride Diagnostics, Inc.
Decision Date1998-06-29
Product CodeCEC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOSTRIDE FREE T4 EIA TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Biostride Diagnostics, Inc.. It received FDA 510(k) clearance on 1998-06-29 under 510(k) number K981243. 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 BIOSTRIDE FREE T4 EIA TEST KIT?

BIOSTRIDE FREE T4 EIA TEST KIT is a medical device that received FDA 510(k) clearance on 1998-06-29. The listed applicant is Biostride Diagnostics, Inc.. The 510(k) number is K981243.

When did BIOSTRIDE FREE T4 EIA TEST KIT receive FDA 510(k) clearance?

BIOSTRIDE FREE T4 EIA TEST KIT received FDA 510(k) clearance on 1998-06-29, under 510(k) number K981243.

Who is the listed applicant for BIOSTRIDE FREE T4 EIA TEST KIT?

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

What is the FDA product code for BIOSTRIDE FREE T4 EIA TEST KIT?

The FDA product code for BIOSTRIDE FREE T4 EIA TEST KIT is CEC.

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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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