Cleared Traditional

CalSet IGF-1

K170938 · Roche Diagnostics · Chemistry
Apr 2017
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K170938 is an FDA 510(k) clearance for the CalSet IGF-1, a Calibrator, Secondary (Class II — Special Controls, product code JIT), submitted by Roche Diagnostics (Indianapolos, US). The FDA issued a Cleared decision on April 26, 2017, 27 days after receiving the submission on March 30, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K170938 FDA.gov
FDA Decision Cleared SESE
Date Received March 30, 2017
Decision Date April 26, 2017
Days to Decision 27 days
Submission Type Traditional
Review Panel Chemistry (CH)
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
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
Lumipulse G Prolactin
K163544 · Fujirebio Diagnostics,Inc. · Jan 2017