Cleared Traditional

TRIGLYCERIDE AQUEOUS STANDARDS

K840218 · Preventive Diagnostics Corp. · Chemistry
Mar 1984
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K840218 is an FDA 510(k) clearance for the TRIGLYCERIDE AQUEOUS STANDARDS, a Calibrator, Secondary (Class II — Special Controls, product code JIT), submitted by Preventive Diagnostics Corp. (Mchenry, US). The FDA issued a Cleared decision on March 23, 1984, 64 days after receiving the submission on January 19, 1984. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K840218 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 1984
Decision Date March 23, 1984
Days to Decision 64 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JIT — Calibrator, Secondary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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