EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZER— 510(k) K063376

Name: FDA 510(k) clearance K063376
Creator: U.S. Food and Drug Administration
Published: 2007-06-25

Substantially Equivalent

Medica Corp.

FDA 510(k) clearance K063376 for EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZER, Substantially Equivalent on 2007-06-25. Applicant: Medica Corp.. Device class: 2.

Clearance details

Applicant: Medica Corp.
Product code: Code CHL
Device class: Class 2
Regulation: 21 CFR 862.1120
Advisory panel: Clinical Chemistry
Date received: 2006-11-08
Decision date: 2007-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CHL

view all

K252207 — ABL90 FLEX PLUS System, safeCLINITUBES2026-04-10
K244014 — i-STAT CG4+ cartridge with the i-STAT 1 System2025-05-02
K240998 — ABL90 FLEX PLUS System2024-12-13
K230285 — i-STAT CG8+ cartridge with the i-STAT 1 System2023-10-27
K221900 — Stat Profile Prime Plus Analyzer System2023-09-29

More clearances from Medica Corp.

view all

K123802 — EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT2013-03-01
K120497 — EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL2012-05-14
K111363 — PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL2011-12-06
K111005 — ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL2011-11-15
K112788 — EASTLYTE NA/K/CA/PH2011-10-20

Adverse events under product code CHL

product code CHL

Death: 20
Malfunction: 999
Total: 1,019

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.