Cleared Traditional

CLINIQA LIQUID QC TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3, AND TRI LEVEL

K030705 · Cliniqa Corporation · Chemistry
Mar 2003
Decision
20d
Days
Class 1
Risk

About This 510(k) Submission

K030705 is an FDA 510(k) clearance for the CLINIQA LIQUID QC TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3, AND TRI LEVEL, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Cliniqa Corporation (Fallbrook, US). The FDA issued a Cleared decision on March 26, 2003, 20 days after receiving the submission on March 6, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K030705 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 2003
Decision Date March 26, 2003
Days to Decision 20 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JJY — Multi-analyte Controls, All Kinds (assayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

Similar Devices — JJY Multi-analyte Controls, All Kinds (assayed)

All 672
Multichem IA Plus
K162530 · Techno-Path Manufacturing · Mar 2017
Audit MicroControls Linearity FD Tumor Markers II
K163629 · Aalto Scientific, Ltd. · Mar 2017
Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak
K163015 · Bio-Rad Laboratories · Jan 2017
VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit
K153712 · Radiometer America, Inc. · Jan 2016
Liquichek Cardiac Markers Plus Control LT
K150300 · Bio-Rad Laboratories · Dec 2015
VALIDATE Anemia Calibration Verification/ Linearity Test Kit
K142964 · Maine Standards Company, LLC · Apr 2015

More from Cliniqa Corporation

View all
I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2
K120900 · GGN · May 2013
BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LE
K121237 · JJX · May 2012
CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3
K083554 · JJY · Apr 2009
CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2
K081908 · JJW · Jan 2009
CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2
K082107 · JJY · Sep 2008