Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

IN VITRO DIGOXIN RIA TEST

K-Number: K772110 · 1977-11-22

ApplicantClinical Assays, Inc.
Decision Date1977-11-22
Product CodeDNL
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

IN VITRO DIGOXIN RIA TEST 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 1977-11-22 under 510(k) number K772110. The device is classified under product code DNL. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IN VITRO DIGOXIN RIA TEST?

IN VITRO DIGOXIN RIA TEST is a medical device that received FDA 510(k) clearance on 1977-11-22. The listed applicant is Clinical Assays, Inc.. The 510(k) number is K772110.

When did IN VITRO DIGOXIN RIA TEST receive FDA 510(k) clearance?

IN VITRO DIGOXIN RIA TEST received FDA 510(k) clearance on 1977-11-22, under 510(k) number K772110.

Who is the listed applicant for IN VITRO DIGOXIN RIA TEST?

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 DIGOXIN RIA TEST?

The FDA product code for IN VITRO DIGOXIN RIA TEST is DNL.

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 Clinical Assays, 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.

K832711VITAMIN B12 FOLATE CA-1515-125K832710VITAMIN B12 RADIOASSAY KIT CA-1534K832712FOLATE RADIOASSAY KIT CA-1562-125K823476GAMMADAB LH RADIO-KIT #CA-1508K823313IN VITRO GAMMACOAT B-HCG RADIO. TESTK821611GAMMADAB [125] FSH RADIOIMMUNAY KIT

View all 27 devices →

Related Devices (Code: DNL)

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.

K852343DIG RADIOIMMUNOASSAY TEST SYSTEMM Nobird, Inc.K852291TIPSEP DIGOXIN RIANuclear Diagnostics, Inc.K811212DIGOXIN (RIA) KITImmuno Assay Corp.K810966DIAGOXIN SQUIBB RADIOIMMUNOASSAY KITE. R. Squibb & Sons, Inc.K802841DIGOXIN RADIOIMMUNOASSAY KITAmerican Diagnostic Corp.K781834TEST SET, 125 I-DIGOXINWien Laboratories, 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.

↑