Medical Device Manufacturer · US , Culver City , CA

Careside, Inc.

22 submissions · 22 cleared · Since 1998
22
Total
22
Cleared
0
Denied

Careside, Inc. — FDA 510(k) Submissions

Careside, Inc. has submitted 22 FDA 510(k) premarket notifications since 1998, of which 22 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Diazo Colorimetry, Bilirubin, Differential Rate Kinetic Method, Cpk Or Isoenzymes, Test, Time, Prothrombin, Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides, Photometric Method, Ammonia . Use the specialty filter in the sidebar to narrow results.

22 devices
1–22 of 22
CARESIDE LDH
K020484 · CFH Tetrazolium Int... · Chemistry
Jul 2002 140d
CARESIDE GGT
K020486 · JPZ Colorimetric Method,... · Chemistry
Jul 2002 138d
CARESIDE ALT
K020487 · CKA Nadh Oxidation/nad... · Chemistry
Jun 2002 111d
CARESIDE TRGLYCERIDE
K020488 · CDT Lipase... · Chemistry
Apr 2002 61d
CARESIDE CHOLINESTERASE
K002792 · DIH Colorimetry, Cholinesterase · Chemistry
Nov 2000 62d
CARESIDE HEMOGLOBIN
K001462 · KHG Whole Blood Hemoglobin... · Hematology
Aug 2000 103d
CARESIDE DIRECT BILIRUBIN
K993771 · CIG Diazo Colorimetry, Bilirubin · Chemistry
Dec 1999 49d
CARESIDE ANALYZER
K993634 · JJF Analyzer, Chemistry,... · Chemistry
Dec 1999 36d
CARESIDE CO2, TOTAL
K992475 · KHS Enzymatic, Carbon-dioxide · Chemistry
Sep 1999 51d
CARESIDE MG
K991717 · JGJ Photometric Method,... · Chemistry
Aug 1999 82d
CARESIDE AMMONIA
K991371 · JID Photometric Method, Ammonia · Chemistry
Aug 1999 105d
CARESIDE PT
K991065 · GJS Test, Time, Prothrombin · Hematology
Jul 1999 117d
CARESIDE CKMB
K990434 · JHS Differential Rate Kinetic... · Chemistry
Apr 1999 67d
CARESIDE CK
K990439 · JHS Differential Rate Kinetic... · Chemistry
Apr 1999 67d
CARESIDE LYTES, CARESIDE ANALLYZER MODEL 1000
K990036 · JGS Electrode, Ion Specific,... · Chemistry
Mar 1999 71d
CARESIDE AST
K990009 · CIT Nadh Oxidation/nad... · Chemistry
Mar 1999 71d
CARESIDE AMYLASE
K990025 · JFJ Catalytic Methods, Amylase · Chemistry
Feb 1999 35d
CARESIDE ALKALINE PHOSPHATASE
K990024 · CJE Nitrophenylphosphate,... · Chemistry
Jan 1999 8d
CARESIDE CALCIUM, ORIGINAL
K983789 · CJY Azo Dye, Calcium · Chemistry
Dec 1998 51d
CARESIDE URIC ACID
K981604 · KNK Acid, Uric, Uricase... · Chemistry
Jun 1998 58d
CARESIDE ANALYZER
K981610 · CEO Phosphomolybdate... · Chemistry
Jun 1998 56d
CARESIDE TOTAL BILIRUBIN
K981588 · CIG Diazo Colorimetry, Bilirubin · Chemistry
Jun 1998 50d
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