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FDA 510(k)

FREE T3 RADIOIMMUNOASSAY KIT

K-Number: K894200 · 1989-09-25

ApplicantAdvanced Magnetics, Inc.
Decision Date1989-09-25
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FREE T3 RADIOIMMUNOASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Magnetics, Inc.. It received FDA 510(k) clearance on 1989-09-25 under 510(k) number K894200. 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 FREE T3 RADIOIMMUNOASSAY KIT?

FREE T3 RADIOIMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1989-09-25. The listed applicant is Advanced Magnetics, Inc.. The 510(k) number is K894200.

When did FREE T3 RADIOIMMUNOASSAY KIT receive FDA 510(k) clearance?

FREE T3 RADIOIMMUNOASSAY KIT received FDA 510(k) clearance on 1989-09-25, under 510(k) number K894200.

Who is the listed applicant for FREE T3 RADIOIMMUNOASSAY KIT?

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

What is the FDA product code for FREE T3 RADIOIMMUNOASSAY KIT?

The FDA product code for FREE T3 RADIOIMMUNOASSAY KIT is CDP.

Related Clinical Trials

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.

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Other records listing Advanced Magnetics, 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.

K902748SEROZYME FREE T3 IMMUNOASSAYK900060FREE T4 IMMUNOASSAY KITK884753MODIFIED FREE T4 RADIOIMMUNOASSAY KIT

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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