Cleared Traditional

CALIBRATING SOLUTION FOR ABL-1 & 2

K831018 · Fisher Scientific Co., LLC · Chemistry
Jun 1983
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K831018 is an FDA 510(k) clearance for the CALIBRATING SOLUTION FOR ABL-1 & 2, a Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (Class II — Special Controls, product code CHL), submitted by Fisher Scientific Co., LLC (Mchenry, US). The FDA issued a Cleared decision on June 16, 1983, 78 days after receiving the submission on March 30, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K831018 FDA.gov
FDA Decision Cleared SESE
Date Received March 30, 1983
Decision Date June 16, 1983
Days to Decision 78 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CHL — Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1120

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