Cleared Traditional

STA-HYBRID HEP CALIBRATOR

K092937 · Diagnostica Stago, Inc. · Hematology
Aug 2010
Decision
312d
Days
Class 2
Risk

About This 510(k) Submission

K092937 is an FDA 510(k) clearance for the STA-HYBRID HEP CALIBRATOR, a Calibrator, Secondary (Class II — Special Controls, product code JIT), submitted by Diagnostica Stago, Inc. (Parisppany, US). The FDA issued a Cleared decision on August 2, 2010, 312 days after receiving the submission on September 24, 2009. This device falls under the Hematology review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K092937 FDA.gov
FDA Decision Cleared SESE
Date Received September 24, 2009
Decision Date August 02, 2010
Days to Decision 312 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

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

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