FDA 510(k)

SIMULTRAC NEONATAL T4(57CO)/TSH(125I) RADIOIMMUNO.

K-Number: K861920 · 1986-06-16

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic

Decision Date1986-06-16

Product CodeJLW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

SIMULTRAC NEONATAL T4(57CO)/TSH(125I) RADIOIMMUNO. is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1986-06-16 under 510(k) number K861920. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIMULTRAC NEONATAL T4(57CO)/TSH(125I) RADIOIMMUNO.?

SIMULTRAC NEONATAL T4(57CO)/TSH(125I) RADIOIMMUNO. is a medical device that received FDA 510(k) clearance on 1986-06-16. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K861920.

When did SIMULTRAC NEONATAL T4(57CO)/TSH(125I) RADIOIMMUNO. receive FDA 510(k) clearance?

SIMULTRAC NEONATAL T4(57CO)/TSH(125I) RADIOIMMUNO. received FDA 510(k) clearance on 1986-06-16, under 510(k) number K861920.

Who is the listed applicant for SIMULTRAC NEONATAL T4(57CO)/TSH(125I) RADIOIMMUNO.?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIMULTRAC NEONATAL T4(57CO)/TSH(125I) RADIOIMMUNO.?

The FDA product code for SIMULTRAC NEONATAL T4(57CO)/TSH(125I) RADIOIMMUNO. is JLW.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Bd Becton Dickinson Vacutainer Systems Preanalytic as applicant

K003062BACTEC MGIT 960 SIR KITS K0035530.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE K003461BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE K002938B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16 K001364BD DIRECTIGEN FLU A+B K000762MOXIFLOXACIN, 5 UG, BBL SENSI-DISC

View all 632 devices →

Related Devices (Code: JLW)

K251543Atellica® IM TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc.K243570Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)Siemens Healthcare Diagnostics K234091Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0Genalyte, Inc.K233050ADVIA Centaur® TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc.K222116Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)Siemens Healthcare Diagnostics, Inc.K221225Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay AnalyzerBeckman Coulter, 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.