Cleared Abbreviated

ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH)

K042307 · Seradyn, Inc. · Chemistry
Nov 2004
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K042307 is an FDA 510(k) clearance for the ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH), a Calibrator, Secondary (Class II — Special Controls, product code JIT), submitted by Seradyn, Inc. (Indianapolis, US). The FDA issued a Cleared decision on November 3, 2004, 70 days after receiving the submission on August 25, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K042307 FDA.gov
FDA Decision Cleared SESE
Date Received August 25, 2004
Decision Date November 03, 2004
Days to Decision 70 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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