Alpkem Corp.: FDA filings under this applicant name
FDA lists 33 510(k) clearances under the applicant name “Alpkem Corp.” (first 1985, latest 1990), across 27 product codes in 2 review panels. Median 510(k) review time under this name: 25 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 2 | 2 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 2 | 2 |
| CGA | Glucose Oxidase, Glucose | 2 | 2 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 2 | 2 |
| JJF | Analyzer, Chemistry, Micro, For Clinical Use | 2 | 2 |
| KNK | Acid, Uric, Uricase (Colorimetric) | 2 | 2 |
| CEK | Biuret (Colorimetric), Total Protein | 1 | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 | 1 |
| CGE | Orthotoluidine, Glucose | 1 | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 | 1 |
Plus 17 more product codes.
Review panels
- Clinical Chemistry (32)
- Dental (1)
Most recent Alpkem Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K894011 | TOTAL GALACTOSE | KQP | 1990-01-11 | 219 |
| K891070 | PHENYLALANINE (NINHYDRIN REACTION) | JNB | 1989-10-27 | 240 |
| K890334 | TOTAL CHOLESTEROL REAGENT | CHH | 1989-05-03 | 100 |
| K890337 | TRIGLYCERIDES - GPO REAGENT | CDT | 1989-03-09 | 45 |
| K890336 | GLUCOSE (GOD) REAGENT | CGA | 1989-02-27 | 35 |
| K890335 | SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU. | CGE | 1989-02-17 | 25 |
| K890333 | ALBUMIN REAGENT | EIX | 1989-02-17 | 25 |
| K890332 | RFA/2 RAPID FLOW ANALYZER W/COMPUTER | JJC | 1989-02-17 | 25 |
| K883020 | RFA-300 RAPID FLOW ANALYZER W/COMPUTER | JJF | 1988-09-02 | 45 |
| K860367 | MAGNESIUM (SUBSTRATE, ENZYME, REAGENT) | JGF | 1986-04-11 | 67 |
23 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Alpkem Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Alpkem Corp.?
FDA lists 33 510(k) clearances under the applicant name “Alpkem Corp.” (first 1985, latest 1990), across 27 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Alpkem Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Alpkem Corp. is 25 days.
Which FDA product codes appear under Alpkem Corp.?
The most frequent FDA product codes under this applicant name are CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, 2); CFJ (Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase, 2); CGA (Glucose Oxidase, Glucose, 2).
Next steps
- See all 33 Alpkem Corp. clearances with predicates and recalls
- Run predicate analysis for product code CDT, Alpkem Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.