Alpkem Corp.
Medical device manufacturer in Clackamas, OR.
33510(k) clearances
0PMA approvals
0recalls
Device types
- KNK Acid, Uric, Uricase (Colorimetric) 2
- CGA Glucose Oxidase, Glucose 2
- CFJ Nad Reduction/Nadh Oxidation, Lactate… 2
- JJF Analyzer, Chemistry, Micro, For Clinical Use 2
- CHH Enzymatic Esterase--Oxidase, Cholesterol 2
- CDT Lipase Hydrolysis/Glycerol Kinase Enzyme… 2
- CIG Diazo Colorimetry, Bilirubin 1
- KQP Fluorescent Proc. (Qual.), Galactose-1-Phosp… 1
- CIC Cresolphthalein Complexone, Calcium 1
- JIX Calibrator, Multi-Analyte Mixture 1
- CEK Biuret (Colorimetric), Total Protein 1
- JFJ Catalytic Methods, Amylase 1
- JQB Kinetic Method, Gamma-Glutamyl Transpeptidase 1
- CIT Nadh Oxidation/Nad Reduction, Ast/Sgot 1
- CEO Phosphomolybdate (Colorimetric), Inorganic… 1
- CIX Bromcresol Green Dye-Binding, Albumin 1
- CGS Nad Reduction/Nadh Oxidation, Cpk Or… 1
- CJE Nitrophenylphosphate, Alkaline Phosphatase… 1
- CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt 1
- CGX Alkaline Picrate, Colorimetry, Creatinine 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K894011 | Total GalactoseKQP · Traditional | 01/11/1990SE |
| K891070 | Phenylalanine (Ninhydrin Reaction)JNB · Traditional | 10/27/1989SE |
| K890334 | Total Cholesterol ReagentCHH · Traditional | 05/03/1989SE |
| K890337 | Triglycerides - Gpo ReagentCDT · Traditional | 03/09/1989SE |
| K890336 | Glucose (God) ReagentCGA · Traditional | 02/27/1989SE |
| K890335 | Sodium Hydroxide Solution, Creatinine Reag./Dilu.CGE · Traditional | 02/17/1989SE |
| K890333 | Albumin ReagentEIX · Traditional | 02/17/1989SE |
| K890332 | RFA/2 Rapid Flow Analyzer W/ComputerJJC · Traditional | 02/17/1989SE |
| K883020 | RFA-300 Rapid Flow Analyzer W/ComputerJJF · Traditional | 09/02/1988SE |
| K860367 | Magnesium (Substrate, Enzyme, Reagent)JGF · Traditional | 04/11/1986SE |
| K852005 | MG ReagentJGJ · Traditional | 06/25/1985SE |
| K852002 | Ca Buffer Ca DyeCIC · Traditional | 06/25/1985SE |
| K851990 | Internal Standard Solution, External Standard SoluJIX · Traditional | 06/25/1985SE |
| K852006 | TP Biuret ReagentCEK · Traditional | 06/10/1985SE |
| K852001 | Amy ReagentJFJ · Traditional | 06/10/1985SE |
| K851999 | G-Gt ReagentJQB · Traditional | 06/10/1985SE |
| K851994 | Ast Aspartate Aminotransferase ReagentCIT · Traditional | 06/03/1985SE |
| K852003 | Ip Acid Reagent Ip Moly Bdate ReagentCEO · Traditional | 05/31/1985SE |
| K851996 | Ld-L ReagentCFJ · Traditional | 05/31/1985SE |
| K852010 | TGL ReagentCDT · Traditional | 05/30/1985SE |
| K852009 | T-Cho ReagentCHH · Traditional | 05/30/1985SE |
| K852008 | T-Bil Reagent, D-Bil Reagent, Sodium Nitrite & SulCIG · Traditional | 05/30/1985SE |
| K852007 | Alb BCG ReagentCIX · Traditional | 05/30/1985SE |
| K852000 | Ck-Nac ReagentCGS · Traditional | 05/30/1985SE |
| K851998 | Alp(Alkaline)(Phosphatase) ReagentCJE · Traditional | 05/30/1985SE |
| K851997 | Ld-P ReagentCFJ · Traditional | 05/30/1985SE |
| K851995 | Alt (Alanine Amino-Thransferase)ReagentCKA · Traditional | 05/30/1985SE |
| K851993 | Cre Buffer Cre DyeCGX · Traditional | 05/30/1985SE |
| K852004 | Ua(Uricase) ReagentKNK · Traditional | 05/29/1985SE |
| K851992 | Glu(God) ReagentCGA · Traditional | 05/29/1985SE |
| K851991 | Un(Urease)Reagent Un(A-Keto)ReagentKNK · Traditional | 05/29/1985SE |
| K851638 | Clinalyzer Model VX-1000JJE · Traditional | 05/13/1985SE |
| K851542 | RFA-300 Rapid Flow Analyzer W/ComputerJJF · Traditional | 05/10/1985SE |