Cleared Traditional

FISHER DIAGNOSTICS SERA CHEM SMAC CALIBRATORS

K844047 · Fisher Diagnostics · Chemistry
Nov 1984
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K844047 is an FDA 510(k) clearance for the FISHER DIAGNOSTICS SERA CHEM SMAC CALIBRATORS, a Calibrator, Secondary (Class II — Special Controls, product code JIT), submitted by Fisher Diagnostics (Orangeburg, US). The FDA issued a Cleared decision on November 9, 1984, 23 days after receiving the submission on October 17, 1984. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K844047 FDA.gov
FDA Decision Cleared SESE
Date Received October 17, 1984
Decision Date November 09, 1984
Days to Decision 23 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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