Cleared Abbreviated

BAYER ADVIA IMS PSA CALIBRATOR AND ADVIA IMS CPSA CALIBRATORS

K061139 · Bayer Healthcare, LLC · Immunology
Jul 2006
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K061139 is an FDA 510(k) clearance for the BAYER ADVIA IMS PSA CALIBRATOR AND ADVIA IMS CPSA CALIBRATORS, a Calibrator, Secondary (Class II — Special Controls, product code JIT), submitted by Bayer Healthcare, LLC (Tarrytown, US). The FDA issued a Cleared decision on July 6, 2006, 73 days after receiving the submission on April 24, 2006. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K061139 FDA.gov
FDA Decision Cleared SESE
Date Received April 24, 2006
Decision Date July 06, 2006
Days to Decision 73 days
Submission Type Abbreviated
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code JIT — Calibrator, Secondary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

Similar Devices — JIT Calibrator, Secondary

All 244
VITROS Immunodiagnostic Products Insulin Calibrators
K171168 · Ortho-Clinical Diagnostics · May 2017
CalSet IGF-1
K170938 · Roche Diagnostics · Apr 2017
Abbott ARCHITECT Free T3
K170160 · Abbott Laboratories · Feb 2017
Lumipulse G FSH-N Calibrators
K163534 · Fujirebio Diagnostics,Inc. · Jan 2017
Lumipulse G Progesterone-N Calibrators
K163546 · Fujirebio Diagnostics,Inc. · Jan 2017
Lumipulse G LH Calibrators
K163521 · Fujirebio Diagnostics,Inc. · Jan 2017