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)

REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)

K-Number: K001607 · 2000-10-05

ApplicantRepromedix Corp.
Decision Date2000-10-05
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104) is the device name listed in this FDA 510(k) record. The listed applicant is Repromedix Corp.. It received FDA 510(k) clearance on 2000-10-05 under 510(k) number K001607. The device is classified under product code CDP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)?

REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104) is a medical device that received FDA 510(k) clearance on 2000-10-05. The listed applicant is Repromedix Corp.. The 510(k) number is K001607.

When did REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104) receive FDA 510(k) clearance?

REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104) received FDA 510(k) clearance on 2000-10-05, under 510(k) number K001607.

Who is the listed applicant for REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)?

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

What is the FDA product code for REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)?

The FDA product code for REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104) is CDP.

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 Repromedix 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.

K001603REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105)K001606REPROBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 107)

Related Devices (Code: CDP)

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.

K991692CHIRON DIAGNOSTICS ACS: 180 FT3Chiron Diagnostics Corp.K991311TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005Biocheck, Inc.K991252AIA-PACK FT3 ASSAYTosoh Medics, Inc.K981824OPTICOAT T3 EIA KITBiotecx Laboratories, Inc.K983439ABBOTT ARCHITECT FREE T3Abbott LaboratoriesK983434ABBOTT ARCHITECT TOTAL T3Abbott Laboratories

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.

↑