FDA 510(k)

MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT

K-Number: K060348 · 2006-02-27

Decision Date2006-02-27

Product CodeCEW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Scantibodies Laboratory, Inc.. It received FDA 510(k) clearance on 2006-02-27 under 510(k) number K060348. The device is classified under product code CEW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT?

MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT is a medical device that received FDA 510(k) clearance on 2006-02-27. The listed applicant is Scantibodies Laboratory, Inc.. The 510(k) number is K060348.

When did MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT receive FDA 510(k) clearance?

MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT received FDA 510(k) clearance on 2006-02-27, under 510(k) number K060348.

Who is the listed applicant for MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT?

The FDA 510(k) record lists Scantibodies Laboratory, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT?

The FDA product code for MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT is CEW.

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 Scantibodies Laboratory, Inc. as applicant

K060578CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION)K060420MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY KIT, MODEL 3KG002 K051888TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013 K051810WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL 3KG014 K051150TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT K051141WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILUMINOMETRIC ASSAY (ICMA), MODEL 3KG002

View all 19 devices →

Related Devices (Code: CEW)

K231927Elecsys PTH , Elecsys PTH STATRoche Diagnostics K232791Access Intact PTHBeckman Coulter, Inc.K221197VITROS Immunodiagnostic Products Intact PTH II Reagent PackOrtho Clinical Diagnostics K190702Lumipulse G whole PTHFujirebio Diagnostics,Inc.K163658ADVIA Centaur Intact Parathyroid Hormone (PTH) AssaySiemens Healthcare Diagnostics, Inc.K161158IDS-iSYS Intact PTHNImmunodiagnostic Systems , Ltd.

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.