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FDA 510(k)

DIAGNOSTIC KIT FREE T3 AND FREE T4

K-Number: K870268 · 1987-09-14

ApplicantSclavo, Inc.
Decision Date1987-09-14
Product CodeCEC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIAGNOSTIC KIT FREE T3 AND FREE T4 is the device name listed in this FDA 510(k) record. The listed applicant is Sclavo, Inc.. It received FDA 510(k) clearance on 1987-09-14 under 510(k) number K870268. 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 DIAGNOSTIC KIT FREE T3 AND FREE T4?

DIAGNOSTIC KIT FREE T3 AND FREE T4 is a medical device that received FDA 510(k) clearance on 1987-09-14. The listed applicant is Sclavo, Inc.. The 510(k) number is K870268.

When did DIAGNOSTIC KIT FREE T3 AND FREE T4 receive FDA 510(k) clearance?

DIAGNOSTIC KIT FREE T3 AND FREE T4 received FDA 510(k) clearance on 1987-09-14, under 510(k) number K870268.

Who is the listed applicant for DIAGNOSTIC KIT FREE T3 AND FREE T4?

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

What is the FDA product code for DIAGNOSTIC KIT FREE T3 AND FREE T4?

The FDA product code for DIAGNOSTIC KIT FREE T3 AND FREE T4 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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