LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A - E FOR BECKMAN COULTER SYNCHRON SYSTEMS— 510(k) K031921

Name: FDA 510(k) clearance K031921
Creator: U.S. Food and Drug Administration
Published: 2003-08-25

Substantially Equivalent

Cliniqa Corporation

FDA 510(k) clearance K031921 for LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A - E FOR BECKMAN COULTER SYNCHRON SYSTEMS, Substantially Equivalent on 2003-08-25. Applicant: Cliniqa Corporation. Device class: 1.

Clearance details

Applicant: Cliniqa Corporation
Product code: Code JJY
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 2003-06-23
Decision date: 2003-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fallbrook, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JJY

view all

K162530 — Multichem IA Plus2017-03-31
K163629 — Audit MicroControls Linearity FD Tumor Markers II2017-03-10
K163015 — Liquichek Tumor Marker Control-Level 1 +3 more2017-01-10
K153712 — VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit2016-01-28
K150300 — Liquichek Cardiac Markers Plus Control LT2015-12-11

More clearances from Cliniqa Corporation

view all

K120900 — I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 22013-05-31
K121237 — BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LE2012-05-18
K083554 — CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 32009-04-21
K081908 — CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 22009-01-16
K082107 — CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 22008-09-17

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