Company ยท US
Alpkem Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 1990. Name variants (Inc, Corp, punctuation) are merged.
33510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 2 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 2 |
| CGA | Glucose Oxidase, Glucose | 2 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 2 |
| JJF | Analyzer, Chemistry, Micro, For Clinical Use | 2 |
| KNK | Acid, Uric, Uricase (Colorimetric) | 2 |
| CEK | Biuret (Colorimetric), Total Protein | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 |
| CGE | Orthotoluidine, Glucose | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 |
| CIC | Cresolphthalein Complexone, Calcium | 1 |
| CIG | Diazo Colorimetry, Bilirubin | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 1 |
| EIX | Probe, Periodontic | 1 |
| JFJ | Catalytic Methods, Amylase | 1 |
| JGF | Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 11, 1990 | K894011 | TOTAL GALACTOSE Alpkem Corp. | KQP |
| Oct 27, 1989 | K891070 | PHENYLALANINE (NINHYDRIN REACTION) Alpkem Corp. | JNB |
| May 3, 1989 | K890334 | TOTAL CHOLESTEROL REAGENT Alpkem Corp. | CHH |
| Mar 9, 1989 | K890337 | TRIGLYCERIDES - GPO REAGENT Alpkem Corp. | CDT |
| Feb 27, 1989 | K890336 | GLUCOSE (GOD) REAGENT Alpkem Corp. | CGA |
| Feb 17, 1989 | K890335 | SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU. Alpkem Corp. | CGE |
| Feb 17, 1989 | K890333 | ALBUMIN REAGENT Alpkem Corp. | EIX |
| Feb 17, 1989 | K890332 | RFA/2 RAPID FLOW ANALYZER W/COMPUTER Alpkem Corp. | JJC |
| Sep 2, 1988 | K883020 | RFA-300 RAPID FLOW ANALYZER W/COMPUTER Alpkem Corp. | JJF |
| Apr 11, 1986 | K860367 | MAGNESIUM (SUBSTRATE, ENZYME, REAGENT) Alpkem Corp. | JGF |
| Jun 25, 1985 | K852005 | MG REAGENT Alpkem Corp. | JGJ |
| Jun 25, 1985 | K852002 | CA BUFFER CA DYE Alpkem Corp. | CIC |
| Jun 25, 1985 | K851990 | INTERNAL STANDARD SOLUTION, EXTERNAL STANDARD SOLU Alpkem Corp. | JIX |
| Jun 10, 1985 | K852006 | TP BIURET REAGENT Alpkem Corp. | CEK |
| Jun 10, 1985 | K852001 | AMY REAGENT Alpkem Corp. | JFJ |
| Jun 10, 1985 | K851999 | G-GT REAGENT Alpkem Corp. | JQB |
| Jun 3, 1985 | K851994 | AST ASPARTATE AMINOTRANSFERASE REAGENT Alpkem Corp. | CIT |
| May 31, 1985 | K852003 | IP ACID REAGENT IP MOLY BDATE REAGENT Alpkem Corp. | CEO |
| May 31, 1985 | K851996 | LD-L REAGENT Alpkem Corp. | CFJ |
| May 30, 1985 | K852010 | TGL REAGENT Alpkem Corp. | CDT |
| May 30, 1985 | K852009 | T-CHO REAGENT Alpkem Corp. | CHH |
| May 30, 1985 | K852008 | T-BIL REAGENT, D-BIL REAGENT, SODIUM NITRITE & SUL Alpkem Corp. | CIG |
| May 30, 1985 | K852007 | ALB BCG REAGENT Alpkem Corp. | CIX |
| May 30, 1985 | K852000 | CK-NAC REAGENT Alpkem Corp. | CGS |
| May 30, 1985 | K851998 | ALP(ALKALINE)(PHOSPHATASE) REAGENT Alpkem Corp. | CJE |
| May 30, 1985 | K851997 | LD-P REAGENT Alpkem Corp. | CFJ |
| May 30, 1985 | K851995 | ALT (ALANINE AMINO-THRANSFERASE)REAGENT Alpkem Corp. | CKA |
| May 30, 1985 | K851993 | CRE BUFFER CRE DYE Alpkem Corp. | CGX |
| May 29, 1985 | K852004 | UA(URICASE) REAGENT Alpkem Corp. | KNK |
| May 29, 1985 | K851992 | GLU(GOD) REAGENT Alpkem Corp. | CGA |
| May 29, 1985 | K851991 | UN(UREASE)REAGENT UN(A-KETO)REAGENT Alpkem Corp. | KNK |
| May 13, 1985 | K851638 | CLINALYZER MODEL VX-1000 Alpkem Corp. | JJE |
| May 10, 1985 | K851542 | RFA-300 RAPID FLOW ANALYZER W/COMPUTER Alpkem Corp. | JJF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||