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FDA 510(k)

IN VITRO NEONATAL T4

K-Number: K780854 · 1978-07-27

ApplicantClinical Assays, Inc.
Decision Date1978-07-27
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IN VITRO NEONATAL T4 is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Assays, Inc.. It received FDA 510(k) clearance on 1978-07-27 under 510(k) number K780854. 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 IN VITRO NEONATAL T4?

IN VITRO NEONATAL T4 is a medical device that received FDA 510(k) clearance on 1978-07-27. The listed applicant is Clinical Assays, Inc.. The 510(k) number is K780854.

When did IN VITRO NEONATAL T4 receive FDA 510(k) clearance?

IN VITRO NEONATAL T4 received FDA 510(k) clearance on 1978-07-27, under 510(k) number K780854.

Who is the listed applicant for IN VITRO NEONATAL T4?

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

What is the FDA product code for IN VITRO NEONATAL T4?

The FDA product code for IN VITRO NEONATAL T4 is CDX.

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Other records listing Clinical Assays, Inc. as applicant

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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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