Trace Scientific , Ltd.
Medical device manufacturer in Miami, FL.
55510(k) clearances
0PMA approvals
0recalls
Device types
- CIT Nadh Oxidation/Nad Reduction, Ast/Sgot 4
- CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt 4
- CDT Lipase Hydrolysis/Glycerol Kinase Enzyme… 4
- CIG Diazo Colorimetry, Bilirubin 4
- CIX Bromcresol Green Dye-Binding, Albumin 3
- CHH Enzymatic Esterase--Oxidase, Cholesterol 3
- CDQ Urease And Glutamic Dehydrogenase, Urea… 3
- CGS Nad Reduction/Nadh Oxidation, Cpk Or… 3
- CFJ Nad Reduction/Nadh Oxidation, Lactate… 2
- CIC Cresolphthalein Complexone, Calcium 2
- JMO Ferrozine (Colorimetric) Iron Binding… 2
- CJE Nitrophenylphosphate, Alkaline Phosphatase… 1
- CIA Methylthymol Blue, Calcium 1
- CEO Phosphomolybdate (Colorimetric), Inorganic… 1
- KHG Whole Blood Hemoglobin Determination 1
- CIJ Saccharogenic, Amylase 1
- DBM Antimitochondrial Antibody, Indirect… 1
- LFR Glucose Dehydrogenase, Glucose 1
- KNK Acid, Uric, Uricase (Colorimetric) 1
- JGY Colorimetric Method, Triglycerides 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K982121 | Enzymatic Mitochondrial Antibody (M2) ReagentDBM · Traditional | 09/17/1998SE |
| K981123 | UreaCDQ · Traditional | 04/24/1998SE |
| K962890 | Cholesterol-Incorporating Dynamic Stab Tech (DST)CHH · Traditional | 09/27/1996SE |
| K961114 | Ast Incorporating DSTCIT · Traditional | 05/23/1996SE |
| K961123 | Alt Incorporating DSTCKA · Traditional | 04/25/1996SE |
| K952488 | Trace Cobas Mira RangeCIX · Traditional | 10/13/1995SE |
| K932713 | Trace Transferrin ReagentDDQ · Traditional | 09/30/1993SE |
| K923322 | Trace Albumin-Mr ReagentCIX · Traditional | 09/11/1992SE |
| K914731 | Trace Gamma Gt-Ss ReagentJQB · Traditional | 11/19/1991SE |
| K911866 | Trace Total/Direct Bilirubin ReagentCIG · Traditional | 07/17/1991SE |
| K903897 | Triglycerides Reagent Gpo 5 X Conc.CDT · Traditional | 10/01/1990SE |
| K904116 | Iron 5 X Conc ReagentJMO · Traditional | 09/27/1990SE |
| K902678 | Liquid Stable Cholesterol Reagent KitCHH · Traditional | 09/25/1990SE |
| K903896 | Calcium Arsenazo III ReagentCIC · Traditional | 09/13/1990SE |
| K891468 | Ast (Got) Ifcc 2-VIAL Reagent W/Pyridoxyl PhosphatCIT · Traditional | 05/22/1989SE |
| K891470 | Ck-Nac 2-VIAL Reagent W/Substrate StartCGS · Traditional | 05/09/1989SE |
| K890996 | LD1 Isoenzyme Reagent KitJGF · Traditional | 05/05/1989SE |
| K891469 | Alt (GPT) Ifcc 2-VIAL Reagent W/Pyridoxyl PhosphatCKA · Traditional | 04/04/1989SE |
| K890070 | Total Bilirubin Reagent, ConcentratedCIG · Traditional | 03/06/1989SE |
| K881938 | Bicarbonate (CO2) REAGENT-2 VialKHS · Traditional | 06/15/1988SE |
| K881244 | HDL Cholesterol KitLBR · Traditional | 06/10/1988SE |
| K874055 | Iron ReagentJMO · Traditional | 10/28/1987SE |
| K870367 | Chloride Reagent - Thiocyanate MethodCHJ · Traditional | 08/21/1987SE |
| K870362 | Calcium Reagent - Cresolphthalein Complexon MethodCIC · Traditional | 08/21/1987SE |
| K872484 | Modified Enzymatic Bun ReagentCDQ · Traditional | 08/19/1987SE |
| K872483 | Modified Alt (GPT) ReagentCKA · Traditional | 08/19/1987SE |
| K870372 | Albumin Reagent - Bromcresol Green MethodCIX · Traditional | 08/19/1987SE |
| K870371 | Total Protein Reagent - Biuret MethodCEK · Traditional | 08/19/1987SE |
| K870370 | Magnesium Reagent - Calmagite MethodJGJ · Traditional | 08/19/1987SE |
| K870369 | Calcium Reagent-Methyl Thymol Blue MethodCIA · Traditional | 08/19/1987SE |
| K870368 | Phosphorus Reagent-Direct UV Method W/O ReductionCEO · Traditional | 08/19/1987SE |
| K870366 | Creatinine Reagent - Picric Acid MethodCGX · Traditional | 08/19/1987SE |
| K870365 | Direct Bilirubin Reagent - Acid Diazo MethodCIG · Traditional | 08/19/1987SE |
| K870364 | Total Bilirubin Reagent - Dmso MethodCIG · Traditional | 08/19/1987SE |
| K871509 | Resubmitted Triglyceride Gpo Reagent (Single Vial)CDT · Traditional | 05/08/1987SE |
| K871508 | Resubmitted Triglyceride Gpo - Two VialCDT · Traditional | 05/08/1987SE |
| K870363 | Haemoglobin Reagent - Cyanmethaemoglobin MethodKHG · Traditional | 03/16/1987SE |
| K864360 | Ldh-P (Lactic Dehydrogenase) Reagent - Sce · Traditional | 02/06/1987SE |
| K864359 | Ck-Nac Reagent(Creatine Kinase/N-Acetyl Cysteine)CGS · Traditional | 02/06/1987SE |
| K864357 | Ast(Got) (Aspartate Aminotransferase) ReagentCIT · Traditional | 02/06/1987SE |
| K864356 | Amylase ReagentCIJ · Traditional | 01/21/1987SE |
| K860733 | Ck-Nac Reagent Creatine Kinase N-Acetyl CysteineCGS · Traditional | 04/24/1986SE |
| K860716 | Enzymatic Bun ReagentCDQ · Traditional | 04/24/1986SE |
| K860715 | Alp (Alkaline Phosphatase) ReagentCJE · Traditional | 04/24/1986SE |
| K860726 | Enzymatic Glucose Reagent Single Vial Glucose OxidLFR · Traditional | 04/21/1986SE |
| K860732 | Enzymatic Uric Acid ReagentKNK · Traditional | 04/16/1986SE |
| K860717 | Enzymatic Cholesterol Reagent (Single Vial)CHH · Traditional | 04/11/1986SE |
| K860731 | Triglycerides Reagent (Int, Colorimetric)JGY · Traditional | 04/07/1986SE |
| K860730 | Enzymatic Triglycerides Reagent (Single Vial)CDT · Traditional | 04/07/1986SE |
| K860729 | Ldh-P (Lactic Dehydrogenase) ReagentCFJ · Traditional | 04/07/1986SE |
| K860728 | L D H-L (Lactic Dehydrogenase) ReagentCFJ · Traditional | 04/07/1986SE |
| K860727 | Alt(Gpt) (Alanine Aminotransferase) ReagentCKA · Traditional | 04/07/1986SE |
| K860725 | Ast(Got) (Aspartate Aminotransferase) ReagentCIT · Traditional | 04/07/1986SE |
| K860724 | Enzymatic Glucose Reagent (Hexokinase)CFR · Traditional | 04/07/1986SE |
| K860723 | G.T. (Gamma-Glutamyl Transferase) ReagentJPZ · Traditional | 04/07/1986SE |