Company ยท US
Careside, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2002. Name variants (Inc, Corp, punctuation) are merged.
22510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CIG | Diazo Colorimetry, Bilirubin | 2 |
| JHS | Differential Rate Kinetic Method, Cpk Or Isoenzymes | 2 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 |
| CFH | Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 |
| CJY | Azo Dye, Calcium | 1 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 1 |
| DIH | Colorimetry, Cholinesterase | 1 |
| GJS | Test, Time, Prothrombin | 1 |
| JFJ | Catalytic Methods, Amylase | 1 |
| JGJ | Photometric Method, Magnesium | 1 |
| JGS | Electrode, Ion Specific, Sodium | 1 |
| JID | Photometric Method, Ammonia | 1 |
| JJF | Analyzer, Chemistry, Micro, For Clinical Use | 1 |
| JPZ | Colorimetric Method, Gamma-Glutamyl Transpeptidase | 1 |
| KHG | Whole Blood Hemoglobin Determination | 1 |
| KHS | Enzymatic, Carbon-Dioxide | 1 |
| KNK | Acid, Uric, Uricase (Colorimetric) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 3, 2002 | K020484 | CARESIDE LDH Careside, Inc. | CFH |
| Jul 1, 2002 | K020486 | CARESIDE GGT Careside, Inc. | JPZ |
| Jun 4, 2002 | K020487 | CARESIDE ALT Careside, Inc. | CKA |
| Apr 15, 2002 | K020488 | CARESIDE TRGLYCERIDE Careside, Inc. | CDT |
| Nov 8, 2000 | K002792 | CARESIDE CHOLINESTERASE Careside, Inc. | DIH |
| Aug 21, 2000 | K001462 | CARESIDE HEMOGLOBIN Careside, Inc. | KHG |
| Dec 27, 1999 | K993771 | CARESIDE DIRECT BILIRUBIN Careside, Inc. | CIG |
| Dec 2, 1999 | K993634 | CARESIDE ANALYZER Careside, Inc. | JJF |
| Sep 15, 1999 | K992475 | CARESIDE CO2, TOTAL Careside, Inc. | KHS |
| Aug 10, 1999 | K991717 | CARESIDE MG Careside, Inc. | JGJ |
| Aug 3, 1999 | K991371 | CARESIDE AMMONIA Careside, Inc. | JID |
| Jul 26, 1999 | K991065 | CARESIDE PT Careside, Inc. | GJS |
| Apr 19, 1999 | K990439 | CARESIDE CK Careside, Inc. | JHS |
| Apr 19, 1999 | K990434 | CARESIDE CKMB Careside, Inc. | JHS |
| Mar 18, 1999 | K990036 | CARESIDE LYTES, CARESIDE ANALLYZER MODEL 1000 Careside, Inc. | JGS |
| Mar 16, 1999 | K990009 | CARESIDE AST Careside, Inc. | CIT |
| Feb 8, 1999 | K990025 | CARESIDE AMYLASE Careside, Inc. | JFJ |
| Jan 13, 1999 | K990024 | CARESIDE ALKALINE PHOSPHATASE Careside, Inc. | CJE |
| Dec 17, 1998 | K983789 | CARESIDE CALCIUM, ORIGINAL Careside, Inc. | CJY |
| Jun 25, 1998 | K981610 | CARESIDE ANALYZER Careside, Inc. | CEO |
| Jun 25, 1998 | K981604 | CARESIDE URIC ACID Careside, Inc. | KNK |
| Jun 23, 1998 | K981588 | CARESIDE TOTAL BILIRUBIN Careside, Inc. | CIG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||