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FDA 510(k)

THYRO-ZYME-T4 ASSAY KIT

K-Number: K780401 · 1978-04-24

ApplicantCoulter Electronics, Inc.
Decision Date1978-04-24
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

THYRO-ZYME-T4 ASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Coulter Electronics, Inc.. It received FDA 510(k) clearance on 1978-04-24 under 510(k) number K780401. 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 THYRO-ZYME-T4 ASSAY KIT?

THYRO-ZYME-T4 ASSAY KIT is a medical device that received FDA 510(k) clearance on 1978-04-24. The listed applicant is Coulter Electronics, Inc.. The 510(k) number is K780401.

When did THYRO-ZYME-T4 ASSAY KIT receive FDA 510(k) clearance?

THYRO-ZYME-T4 ASSAY KIT received FDA 510(k) clearance on 1978-04-24, under 510(k) number K780401.

Who is the listed applicant for THYRO-ZYME-T4 ASSAY KIT?

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

What is the FDA product code for THYRO-ZYME-T4 ASSAY KIT?

The FDA product code for THYRO-ZYME-T4 ASSAY KIT is CDX.

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Other records listing Coulter Electronics, 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.

K923951CD8 CYTOSPHERES KITK930119COULTER RETIC-C CELL CONTROLK921279CD4 CYTOSPHERES KITK923530COULTER MULTI-Q-PREPK922181COULTER MH009K922704COULTER MAXM W/ AUTOLOADER

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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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