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 PHENOBARBITAL RIA TEST

K-Number: K772111 · 1977-11-28

ApplicantClinical Assays, Inc.
Decision Date1977-11-28
Product CodeDKP
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

IN VITRO PHENOBARBITAL 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 1977-11-28 under 510(k) number K772111. The device is classified under product code DKP. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IN VITRO PHENOBARBITAL RIA TEST?

IN VITRO PHENOBARBITAL RIA TEST is a medical device that received FDA 510(k) clearance on 1977-11-28. The listed applicant is Clinical Assays, Inc.. The 510(k) number is K772111.

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

IN VITRO PHENOBARBITAL RIA TEST received FDA 510(k) clearance on 1977-11-28, under 510(k) number K772111.

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

The FDA product code for IN VITRO PHENOBARBITAL RIA TEST is DKP.

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: DKP)

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.

K844167ARIA HT PHENOBARBITAL RADIOIMMUNOASSAY KITBd Becton Dickinson Vacutainer Systems PreanalyticK800090FLUOROMATIC PHENOLBARBITAL FIABio-Rad

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.

↑