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FDA 510(k)

IMMULITE (TM) TOTAL T3

K-Number: K905214 · 1991-02-01

ApplicantCirrus Diagnostics, Inc.
Decision Date1991-02-01
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMULITE (TM) TOTAL T3 is the device name listed in this FDA 510(k) record. The listed applicant is Cirrus Diagnostics, Inc.. It received FDA 510(k) clearance on 1991-02-01 under 510(k) number K905214. 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 IMMULITE (TM) TOTAL T3?

IMMULITE (TM) TOTAL T3 is a medical device that received FDA 510(k) clearance on 1991-02-01. The listed applicant is Cirrus Diagnostics, Inc.. The 510(k) number is K905214.

When did IMMULITE (TM) TOTAL T3 receive FDA 510(k) clearance?

IMMULITE (TM) TOTAL T3 received FDA 510(k) clearance on 1991-02-01, under 510(k) number K905214.

Who is the listed applicant for IMMULITE (TM) TOTAL T3?

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

What is the FDA product code for IMMULITE (TM) TOTAL T3?

The FDA product code for IMMULITE (TM) TOTAL T3 is CDP.

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Other records listing Cirrus Diagnostics, 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.

K921704IMMULITE(R) FSHK920411IMMULITE HLHK914833IMMULITE DIGOXINK911796IMMULITE(TM) HCGK910677IMMULITE(TM) T-UPTAKEK910261IMMULITE(TM) TOTAL T4

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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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