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FDA 510(k)

AXSYM FREE TRIIODOTHYRONINE (FREE T3)

K-Number: K963827 · 1996-10-30

ApplicantAbbott Laboratories
Decision Date1996-10-30
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AXSYM FREE TRIIODOTHYRONINE (FREE T3) is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1996-10-30 under 510(k) number K963827. The device is classified under product code CDP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXSYM FREE TRIIODOTHYRONINE (FREE T3)?

AXSYM FREE TRIIODOTHYRONINE (FREE T3) is a medical device that received FDA 510(k) clearance on 1996-10-30. The listed applicant is Abbott Laboratories. The 510(k) number is K963827.

When did AXSYM FREE TRIIODOTHYRONINE (FREE T3) receive FDA 510(k) clearance?

AXSYM FREE TRIIODOTHYRONINE (FREE T3) received FDA 510(k) clearance on 1996-10-30, under 510(k) number K963827.

Who is the listed applicant for AXSYM FREE TRIIODOTHYRONINE (FREE T3)?

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

What is the FDA product code for AXSYM FREE TRIIODOTHYRONINE (FREE T3)?

The FDA product code for AXSYM FREE TRIIODOTHYRONINE (FREE T3) is CDP.

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Related Devices (Code: CDP)

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.

K001607REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)Repromedix Corp.K991692CHIRON DIAGNOSTICS ACS: 180 FT3Chiron Diagnostics Corp.K991311TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005Biocheck, Inc.K991252AIA-PACK FT3 ASSAYTosoh Medics, Inc.K981824OPTICOAT T3 EIA KITBiotecx Laboratories, Inc.K983439ABBOTT ARCHITECT FREE T3Abbott Laboratories

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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