A-Kem, Inc.
Clifton, NJ, US
A-Kem, Inc. appears in FDA device records in Clifton, NJ. FDA records list 13 510(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
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for A-Kem, Inc. between 1987 and 1988. The busiest year on record is 1987, with 7. The most recent is 1988, with 6.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1987 | 7 |
| 1988 | 6 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K884224 | TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS | CIG | Substantially Equivalent | |
| K884227 | CALIBRATOR STANDARD KIT FOR ASTRA SYSTEM | JIX | Substantially Equivalent | |
| K884226 | AMYLASE REAGENT KIT FOR ASTRA SYSTEMS | CJA | Substantially Equivalent | |
| K884225 | TOTAL PROTEIN REAGENT KIT FOR ASTRA SYSTEMS | CEK | Substantially Equivalent | |
| K882587 | A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM | CIX | Substantially Equivalent | |
| K882586 | A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM | CIC | Substantially Equivalent | |
| K873132 | BUN REAGENT KIT | LFP | Substantially Equivalent | |
| K873131 | CREATININE REAGENT KIT | CGX | Substantially Equivalent | |
| K873130 | WASH SOLUTION KIT | JJE | Substantially Equivalent | |
| K873129 | CARBON DIOXIDE REAGENT KIT | JFL | Substantially Equivalent | |
| K873128 | GLUCOSE REAGENT KIT | CGA | Substantially Equivalent | |
| K873127 | CHLORIDE REAGENT KIT | JFS | Substantially Equivalent | |
| K873126 | SODIUM/POTASSIUM REAGENT KIT | JGS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CGXAlkaline Picrate, Colorimetry, Creatinine
- CJAAmyloclastic, Amylase
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- CEKBiuret (Colorimetric), Total Protein
- CIXBromcresol Green Dye-Binding, Albumin
- JIXCalibrator, Multi-Analyte Mixture
- LFPConductivity Rate, Urea Nitrogen
- JFSCoulometric, Chloride
- CICCresolphthalein Complexone, Calcium
- CIGDiazo Colorimetry, Bilirubin
- JGSElectrode, Ion Specific, Sodium
- CGAGlucose Oxidase, Glucose
- JFLPh Rate Measurement, Carbon-Dioxide
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain