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)

RIA, INSULIN, DOUBLE ANTIBODY

K-Number: K790630 · 1979-07-24

ApplicantEndocrine-Metabolic Center
Decision Date1979-07-24
Product CodeCFP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RIA, INSULIN, DOUBLE ANTIBODY is the device name listed in this FDA 510(k) record. The listed applicant is Endocrine-Metabolic Center. It received FDA 510(k) clearance on 1979-07-24 under 510(k) number K790630. The device is classified under product code CFP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RIA, INSULIN, DOUBLE ANTIBODY?

RIA, INSULIN, DOUBLE ANTIBODY is a medical device that received FDA 510(k) clearance on 1979-07-24. The listed applicant is Endocrine-Metabolic Center. The 510(k) number is K790630.

When did RIA, INSULIN, DOUBLE ANTIBODY receive FDA 510(k) clearance?

RIA, INSULIN, DOUBLE ANTIBODY received FDA 510(k) clearance on 1979-07-24, under 510(k) number K790630.

Who is the listed applicant for RIA, INSULIN, DOUBLE ANTIBODY?

The FDA 510(k) record lists Endocrine-Metabolic Center as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RIA, INSULIN, DOUBLE ANTIBODY?

The FDA product code for RIA, INSULIN, DOUBLE ANTIBODY is CFP.

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 Endocrine-Metabolic Center 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.

K821131RADIOIMMUNOASSAY PARATHYROID HORMONE MIDK811993RADIOIMMUNOASSAY, FOLLICLE STIMULATINGK811994RADIOIMMUNOASSAY LUTEINIZING HORMONEK810948RADIOIMMUNOASSAY THYROID STIM. HORM. KITK810351RADIOIMMUNOASSAY, TOTAL TRIIODOTHRONIEK800188EMC-M-180, T3 UPTAKE - 100 TUBES

View all 9 devices →

Related Devices (Code: CFP)

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.

K963911ALPCO/MERCODIA INSULIN ELISAAmerican Laboratory Products Co., Ltd.K953084ACCESS ULTRASENSITIVE INSULIN ASSAYBio-Rad Laboratories, Inc.K920109IMX INSULINAbbott LaboratoriesK914820DSL INSULIN RIA (DSL 1600)Diagnostic Systems Laboratories, Inc.K903628AIA-PACK IRITosoh Corp.K901135ENZYMUN TEST(R) INSULINBoehringer Mannheim Corp.

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.

↑