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)

AMERLEX-M T3 RIA KIT FOR SERUM AND PLASMA

K-Number: K860252 · 1986-02-11

ApplicantAmersham Corp.
Decision Date1986-02-11
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMERLEX-M T3 RIA KIT FOR SERUM AND PLASMA is the device name listed in this FDA 510(k) record. The listed applicant is Amersham Corp.. It received FDA 510(k) clearance on 1986-02-11 under 510(k) number K860252. 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 AMERLEX-M T3 RIA KIT FOR SERUM AND PLASMA?

AMERLEX-M T3 RIA KIT FOR SERUM AND PLASMA is a medical device that received FDA 510(k) clearance on 1986-02-11. The listed applicant is Amersham Corp.. The 510(k) number is K860252.

When did AMERLEX-M T3 RIA KIT FOR SERUM AND PLASMA receive FDA 510(k) clearance?

AMERLEX-M T3 RIA KIT FOR SERUM AND PLASMA received FDA 510(k) clearance on 1986-02-11, under 510(k) number K860252.

Who is the listed applicant for AMERLEX-M T3 RIA KIT FOR SERUM AND PLASMA?

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

What is the FDA product code for AMERLEX-M T3 RIA KIT FOR SERUM AND PLASMA?

The FDA product code for AMERLEX-M T3 RIA KIT FOR SERUM AND PLASMA 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 Amersham 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.

K914135AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086K912733AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KITK912766AMERLITE CK-MB ASSAYK904666AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008K902760AMERSHAM TSH CONTROL SERAK901848GADOLINIUM-153 BONE DENSITOMETER SOURCES

View all 94 devices →

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.

K001607REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)Repromedix Corp.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.K983434ABBOTT 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.

↑