Cleared Traditional

PARALLEL FLAME PHOTOMETER & SODIUM

K834248 · American Monitor Corp. · Chemistry
Jan 1984
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K834248 is an FDA 510(k) clearance for the PARALLEL FLAME PHOTOMETER & SODIUM, a Flame Photometry, Sodium (Class II — Special Controls, product code JGT), submitted by American Monitor Corp. (Mchenry, US). The FDA issued a Cleared decision on January 30, 1984, 54 days after receiving the submission on December 7, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1665.

Submission Details

510(k) Number K834248 FDA.gov
FDA Decision Cleared SESE
Date Received December 07, 1983
Decision Date January 30, 1984
Days to Decision 54 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JGT — Flame Photometry, Sodium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1665

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