A-Kem, Inc.: FDA clearances and approvals
A-Kem, Inc. has 13 FDA 510(k) clearances (first 1987, latest 1988), across 13 product codes in 1 review panel. Median 510(k) review time: 74 days.
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 |
|---|---|---|---|
| CEK | Biuret (Colorimetric), Total Protein | 1 | 1 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 | 1 |
| CIC | Cresolphthalein Complexone, Calcium | 1 | 1 |
| CIG | Diazo Colorimetry, Bilirubin | 1 | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 | 1 |
| CJA | Amyloclastic, Amylase | 1 | 1 |
| JFL | Ph Rate Measurement, Carbon-Dioxide | 1 | 1 |
| JFS | Coulometric, Chloride | 1 | 1 |
| JGS | Electrode, Ion Specific, Sodium | 1 | 1 |
Plus 3 more product codes.
Review panels
- Clinical Chemistry (13)
Most recent A-Kem, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K884224 | TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS | CIG | 1988-12-15 | 70 |
| K884227 | CALIBRATOR STANDARD KIT FOR ASTRA SYSTEM | JIX | 1988-12-09 | 64 |
| K884226 | AMYLASE REAGENT KIT FOR ASTRA SYSTEMS | CJA | 1988-12-09 | 64 |
| K884225 | TOTAL PROTEIN REAGENT KIT FOR ASTRA SYSTEMS | CEK | 1988-12-09 | 64 |
| K882587 | A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM | CIX | 1988-08-08 | 46 |
| K882586 | A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM | CIC | 1988-08-08 | 46 |
| K873132 | BUN REAGENT KIT | LFP | 1987-10-23 | 74 |
| K873131 | CREATININE REAGENT KIT | CGX | 1987-10-23 | 74 |
| K873130 | WASH SOLUTION KIT | JJE | 1987-10-23 | 74 |
| K873129 | CARBON DIOXIDE REAGENT KIT | JFL | 1987-10-23 | 74 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named A-Kem, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does A-Kem, Inc. have?
A-Kem, Inc. has 13 FDA 510(k) clearances (first 1987, latest 1988), across 13 product codes in 1 review panel.
How long does FDA take to clear A-Kem, Inc.'s 510(k)s?
The median time from FDA receipt to decision across A-Kem, Inc.'s cleared 510(k)s is 74 days.
What devices does A-Kem, Inc. make?
Its most frequent FDA product codes are CEK (Biuret (Colorimetric), Total Protein, 1); CGA (Glucose Oxidase, Glucose, 1); CGX (Alkaline Picrate, Colorimetry, Creatinine, 1).
Has A-Kem, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching A-Kem, Inc. Related entities may recall under other names.
Next steps
- See all 13 A-Kem, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CEK, A-Kem, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.