Cleared Traditional

EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZER

K063376 · Medica Corp. · Chemistry
Jun 2007
Decision
229d
Days
Class 2
Risk

About This 510(k) Submission

K063376 is an FDA 510(k) clearance for the EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZER, a Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (Class II — Special Controls, product code CHL), submitted by Medica Corp. (Bedford, US). The FDA issued a Cleared decision on June 25, 2007, 229 days after receiving the submission on November 8, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K063376 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 2006
Decision Date June 25, 2007
Days to Decision 229 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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

Similar Devices — CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph

All 186
i-STAT CG4+ cartridge with the i-STAT 1 System
K244014 · Abbott Point of Care, Inc. · May 2025
ABL90 FLEX PLUS System
K240998 · Radiometer Medicals Aps · Dec 2024
i-STAT CG8+ cartridge with the i-STAT 1 System
K230285 · Abbott Point of Care, Inc. · Oct 2023
Stat Profile Prime Plus Analyzer System
K221900 · Nova Biomedical Corporation · Sep 2023
i-STAT G3+ cartridge with the i-STAT 1 System
K223857 · Abbott Point of Care, Inc. · Sep 2023
GEM Premier 7000 with IQM3
K223608 · Instrumentation Laboratory Company · Aug 2023