Cleared Abbreviated

ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10

K082141 · Biokit, S.A. · Chemistry
Sep 2008
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K082141 is an FDA 510(k) clearance for the ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10, a Calibrator, Secondary (Class II — Special Controls, product code JIT), submitted by Biokit, S.A. (Barcelona, ES). The FDA issued a Cleared decision on September 3, 2008, 35 days after receiving the submission on July 30, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K082141 FDA.gov
FDA Decision Cleared SESE
Date Received July 30, 2008
Decision Date September 03, 2008
Days to Decision 35 days
Submission Type Abbreviated
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

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