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FDA 510(k)

T4 RIA

K-Number: K833850 · 1984-01-18

ApplicantSyncor Intl. Corp.
Decision Date1984-01-18
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

T4 RIA is the device name listed in this FDA 510(k) record. The listed applicant is Syncor Intl. Corp.. It received FDA 510(k) clearance on 1984-01-18 under 510(k) number K833850. 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 T4 RIA?

T4 RIA is a medical device that received FDA 510(k) clearance on 1984-01-18. The listed applicant is Syncor Intl. Corp.. The 510(k) number is K833850.

When did T4 RIA receive FDA 510(k) clearance?

T4 RIA received FDA 510(k) clearance on 1984-01-18, under 510(k) number K833850.

Who is the listed applicant for T4 RIA?

The FDA 510(k) record lists Syncor Intl. Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for T4 RIA?

The FDA product code for T4 RIA is CDX.

Other records listing Syncor Intl. Corp. 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.

K945825SECURE SAFETY INSERTK851828IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-CK852023CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41K850433CESIUM 137 ENDOMETRIAL SOURCEK852665SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAYK851033SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KIT

View all 31 devices →

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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