Cleared Traditional

MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR

K984425 · Boehringer Mannheim Corp. · Chemistry
Jan 1999
Decision
40d
Days
Class 2
Risk

About This 510(k) Submission

K984425 is an FDA 510(k) clearance for the MODIFICATION OF 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 January 20, 1999, 40 days after receiving the submission on December 11, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K984425 FDA.gov
FDA Decision Cleared SESE
Date Received December 11, 1998
Decision Date January 20, 1999
Days to Decision 40 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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