Cleared Traditional

PRECISET SERUM PROTEINS CALIBRATOR

K983469 · Boehringer Mannheim Corp. · Chemistry
Nov 1998
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K983469 is an FDA 510(k) clearance for the PRECISET SERUM PROTEINS CALIBRATOR, a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX), submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on November 25, 1998, 55 days after receiving the submission on October 1, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K983469 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 1998
Decision Date November 25, 1998
Days to Decision 55 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JIX — Calibrator, Multi-analyte Mixture
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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