Company ยท US
A-Kem, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1987 to 1988. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CEK | Biuret (Colorimetric), Total Protein | 1 |
| CGA | Glucose Oxidase, Glucose | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 |
| CIC | Cresolphthalein Complexone, Calcium | 1 |
| CIG | Diazo Colorimetry, Bilirubin | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 |
| CJA | Amyloclastic, Amylase | 1 |
| JFL | Ph Rate Measurement, Carbon-Dioxide | 1 |
| JFS | Coulometric, Chloride | 1 |
| JGS | Electrode, Ion Specific, Sodium | 1 |
| JIX | Calibrator, Multi-Analyte Mixture | 1 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 |
| LFP | Conductivity Rate, Urea Nitrogen | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 15, 1988 | K884224 | TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS A-Kem, Inc. | CIG |
| Dec 9, 1988 | K884227 | CALIBRATOR STANDARD KIT FOR ASTRA SYSTEM A-Kem, Inc. | JIX |
| Dec 9, 1988 | K884226 | AMYLASE REAGENT KIT FOR ASTRA SYSTEMS A-Kem, Inc. | CJA |
| Dec 9, 1988 | K884225 | TOTAL PROTEIN REAGENT KIT FOR ASTRA SYSTEMS A-Kem, Inc. | CEK |
| Aug 8, 1988 | K882587 | A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM A-Kem, Inc. | CIX |
| Aug 8, 1988 | K882586 | A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM A-Kem, Inc. | CIC |
| Oct 23, 1987 | K873132 | BUN REAGENT KIT A-Kem, Inc. | LFP |
| Oct 23, 1987 | K873131 | CREATININE REAGENT KIT A-Kem, Inc. | CGX |
| Oct 23, 1987 | K873130 | WASH SOLUTION KIT A-Kem, Inc. | JJE |
| Oct 23, 1987 | K873129 | CARBON DIOXIDE REAGENT KIT A-Kem, Inc. | JFL |
| Oct 23, 1987 | K873128 | GLUCOSE REAGENT KIT A-Kem, Inc. | CGA |
| Oct 23, 1987 | K873127 | CHLORIDE REAGENT KIT A-Kem, Inc. | JFS |
| Oct 23, 1987 | K873126 | SODIUM/POTASSIUM REAGENT KIT A-Kem, Inc. | JGS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||