Cleared Traditional

FLAME PHOTOMETRY REAGENTS

K803051 · Laboratory Products, Inc. · Pathology
Jan 1981
Decision
38d
Days
Class 2
Risk

About This 510(k) Submission

K803051 is an FDA 510(k) clearance for the FLAME PHOTOMETRY REAGENTS, a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX), submitted by Laboratory Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 9, 1981, 38 days after receiving the submission on December 2, 1980. This device falls under the Pathology review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K803051 FDA.gov
FDA Decision Cleared SESE
Date Received December 02, 1980
Decision Date January 09, 1981
Days to Decision 38 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

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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