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FDA 510(k)

ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT

K-Number: K821554 · 1982-06-25

ApplicantAmf Biological and Diagnostics Co.
Decision Date1982-06-25
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT is the device name listed in this FDA 510(k) record. The listed applicant is Amf Biological and Diagnostics Co.. It received FDA 510(k) clearance on 1982-06-25 under 510(k) number K821554. 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 ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT?

ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT is a medical device that received FDA 510(k) clearance on 1982-06-25. The listed applicant is Amf Biological and Diagnostics Co.. The 510(k) number is K821554.

When did ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT receive FDA 510(k) clearance?

ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT received FDA 510(k) clearance on 1982-06-25, under 510(k) number K821554.

Who is the listed applicant for ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT?

The FDA 510(k) record lists Amf Biological and Diagnostics Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT?

The FDA product code for ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT is CDX.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Amf Biological and Diagnostics Co. 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.

K852418QCM-SP1(NORMAL CONCENTTRATION) & SP2(ABNORMAL)K821931ZETA-CORTK821553ZETAPHASE T3 UPTAKE DIAGNOSTIC KITK812329ZETA-SERA D

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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