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FDA 510(k)

FREE THYROXINE(F T4) METHOD/TECHNICON IMMUNO 1(R)

K-Number: K930322 · 1993-11-10

ApplicantHeraeus Kulzer, Inc.
Decision Date1993-11-10
Product CodeCEC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FREE THYROXINE(F T4) METHOD/TECHNICON IMMUNO 1(R) is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, Inc.. It received FDA 510(k) clearance on 1993-11-10 under 510(k) number K930322. 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 FREE THYROXINE(F T4) METHOD/TECHNICON IMMUNO 1(R)?

FREE THYROXINE(F T4) METHOD/TECHNICON IMMUNO 1(R) is a medical device that received FDA 510(k) clearance on 1993-11-10. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K930322.

When did FREE THYROXINE(F T4) METHOD/TECHNICON IMMUNO 1(R) receive FDA 510(k) clearance?

FREE THYROXINE(F T4) METHOD/TECHNICON IMMUNO 1(R) received FDA 510(k) clearance on 1993-11-10, under 510(k) number K930322.

Who is the listed applicant for FREE THYROXINE(F T4) METHOD/TECHNICON IMMUNO 1(R)?

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

What is the FDA product code for FREE THYROXINE(F T4) METHOD/TECHNICON IMMUNO 1(R)?

The FDA product code for FREE THYROXINE(F T4) METHOD/TECHNICON IMMUNO 1(R) is CEC.

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Other records listing Heraeus Kulzer, 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.

K091494FLEXITIME FLOWK063062HKBOND 2006K060994MONDIALK052543HERACERAM ZIRKONIAK043504PALAIMPACTK043295VERSYO.DIRECT

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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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