Cleared Traditional

ABL 735 ANALYZER

K991417 · Radiometer America, Inc. · Chemistry
Nov 1999
Decision
215d
Days
Class 2
Risk

About This 510(k) Submission

K991417 is an FDA 510(k) clearance for the ABL 735 ANALYZER, a Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (Class II — Special Controls, product code CHL), submitted by Radiometer America, Inc. (Westlake, US). The FDA issued a Cleared decision on November 24, 1999, 215 days after receiving the submission on April 23, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K991417 FDA.gov
FDA Decision Cleared SESE
Date Received April 23, 1999
Decision Date November 24, 1999
Days to Decision 215 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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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