Cleared Traditional

VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873;

K052645 · Ortho-Clinical Diagnostics · Microbiology
Dec 2005
Decision
79d
Days
Class 1
Risk

About This 510(k) Submission

K052645 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873;, a Antistreptolysin - Titer/streptolysin O Reagent (Class I — General Controls, product code GTQ), submitted by Ortho-Clinical Diagnostics (Rochester, US). The FDA issued a Cleared decision on December 14, 2005, 79 days after receiving the submission on September 26, 2005. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3720.

Submission Details

510(k) Number K052645 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 2005
Decision Date December 14, 2005
Days to Decision 79 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code GTQ — Antistreptolysin - Titer/streptolysin O Reagent
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3720

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