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FDA 510(k)

TECHNICON DAX SYSTEM THYROXINE (T4) METHOD

K-Number: K922945 · 1992-10-14

ApplicantHeraeus Kulzer, Inc.
Decision Date1992-10-14
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TECHNICON DAX SYSTEM THYROXINE (T4) METHOD 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 1992-10-14 under 510(k) number K922945. The device is classified under product code CDX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TECHNICON DAX SYSTEM THYROXINE (T4) METHOD?

TECHNICON DAX SYSTEM THYROXINE (T4) METHOD is a medical device that received FDA 510(k) clearance on 1992-10-14. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K922945.

When did TECHNICON DAX SYSTEM THYROXINE (T4) METHOD receive FDA 510(k) clearance?

TECHNICON DAX SYSTEM THYROXINE (T4) METHOD received FDA 510(k) clearance on 1992-10-14, under 510(k) number K922945.

Who is the listed applicant for TECHNICON DAX SYSTEM THYROXINE (T4) METHOD?

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 TECHNICON DAX SYSTEM THYROXINE (T4) METHOD?

The FDA product code for TECHNICON DAX SYSTEM THYROXINE (T4) METHOD is CDX.

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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: CDX)

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.

K961490ELECSYS T4 ASSAYBoehringer Mannheim Corp.K954312ACTIVE THYROXINE RIADiagnostic Systems Laboratories, Inc.K943416DELFIA NEONATAL THYROXINE KITWallac OYK934384AXSYM(TM) TOTAL T4Abbott LaboratoriesK932980TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116Sigma Diagnostics, Inc.K933426STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNOBaxter Diagnostics, 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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