Alpkem Corp.
Clackamas, OR, US
Alpkem Corp. appears in FDA device records in Clackamas, OR. FDA records list 33 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 33
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 33 510(k) clearances for Alpkem Corp. between 1985 and 1990. The busiest year on record is 1985, with 23. The most recent is 1990, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 23 |
| 1986 | 1 |
| 1988 | 1 |
| 1989 | 7 |
| 1990 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K894011 | TOTAL GALACTOSE | KQP | Substantially Equivalent | |
| K891070 | PHENYLALANINE (NINHYDRIN REACTION) | JNB | Substantially Equivalent | |
| K890334 | TOTAL CHOLESTEROL REAGENT | CHH | Substantially Equivalent | |
| K890337 | TRIGLYCERIDES - GPO REAGENT | CDT | Substantially Equivalent | |
| K890336 | GLUCOSE (GOD) REAGENT | CGA | Substantially Equivalent | |
| K890335 | SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU. | CGE | Substantially Equivalent | |
| K890333 | ALBUMIN REAGENT | EIX | Substantially Equivalent | |
| K890332 | RFA/2 RAPID FLOW ANALYZER W/COMPUTER | JJC | Substantially Equivalent | |
| K883020 | RFA-300 RAPID FLOW ANALYZER W/COMPUTER | JJF | Substantially Equivalent | |
| K860367 | MAGNESIUM (SUBSTRATE, ENZYME, REAGENT) | JGF | Substantially Equivalent | |
| K852005 | MG REAGENT | JGJ | Substantially Equivalent | |
| K852002 | CA BUFFER CA DYE | CIC | Substantially Equivalent | |
| K851990 | INTERNAL STANDARD SOLUTION, EXTERNAL STANDARD SOLU | JIX | Substantially Equivalent | |
| K852006 | TP BIURET REAGENT | CEK | Substantially Equivalent | |
| K852001 | AMY REAGENT | JFJ | Substantially Equivalent | |
| K851999 | G-GT REAGENT | JQB | Substantially Equivalent | |
| K851994 | AST ASPARTATE AMINOTRANSFERASE REAGENT | CIT | Substantially Equivalent | |
| K852003 | IP ACID REAGENT IP MOLY BDATE REAGENT | CEO | Substantially Equivalent | |
| K851996 | LD-L REAGENT | CFJ | Substantially Equivalent | |
| K852010 | TGL REAGENT | CDT | Substantially Equivalent | |
| K852009 | T-CHO REAGENT | CHH | Substantially Equivalent | |
| K852008 | T-BIL REAGENT, D-BIL REAGENT, SODIUM NITRITE & SUL | CIG | Substantially Equivalent | |
| K852007 | ALB BCG REAGENT | CIX | Substantially Equivalent | |
| K852000 | CK-NAC REAGENT | CGS | Substantially Equivalent | |
| K851998 | ALP(ALKALINE)(PHOSPHATASE) REAGENT | CJE | Substantially Equivalent | |
| K851997 | LD-P REAGENT | CFJ | Substantially Equivalent | |
| K851995 | ALT (ALANINE AMINO-THRANSFERASE)REAGENT | CKA | Substantially Equivalent | |
| K851993 | CRE BUFFER CRE DYE | CGX | Substantially Equivalent | |
| K852004 | UA(URICASE) REAGENT | KNK | Substantially Equivalent | |
| K851992 | GLU(GOD) REAGENT | CGA | Substantially Equivalent | |
| K851991 | UN(UREASE)REAGENT UN(A-KETO)REAGENT | KNK | Substantially Equivalent | |
| K851638 | CLINALYZER MODEL VX-1000 | JJE | Substantially Equivalent | |
| K851542 | RFA-300 RAPID FLOW ANALYZER W/COMPUTER | JJF | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KNKAcid, Uric, Uricase (Colorimetric)
- CGXAlkaline Picrate, Colorimetry, Creatinine
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- JJCAnalyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use
- JJFAnalyzer, Chemistry, Micro, For Clinical Use
- CEKBiuret (Colorimetric), Total Protein
- CIXBromcresol Green Dye-Binding, Albumin
- JIXCalibrator, Multi-Analyte Mixture
- JFJCatalytic Methods, Amylase
- CICCresolphthalein Complexone, Calcium
- CIGDiazo Colorimetry, Bilirubin
- JGFDifferential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- KQPFluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
- CGAGlucose Oxidase, Glucose
- JQBKinetic Method, Gamma-Glutamyl Transpeptidase
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- JNBNinhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- CGEOrthotoluidine, Glucose
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- JGJPhotometric Method, Magnesium
- EIXProbe, Periodontic
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain