A-Kem, Inc.
A-Kem, Inc. appears in FDA public data with 0 recalls, 13 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on December 15, 1988.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 13
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K884224 | TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS | December 15, 1988 |
| K884226 | AMYLASE REAGENT KIT FOR ASTRA SYSTEMS | December 9, 1988 |
| K884227 | CALIBRATOR STANDARD KIT FOR ASTRA SYSTEM | December 9, 1988 |
| K884225 | TOTAL PROTEIN REAGENT KIT FOR ASTRA SYSTEMS | December 9, 1988 |
| K882586 | A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM | August 8, 1988 |
| K882587 | A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM | August 8, 1988 |
| K873130 | WASH SOLUTION KIT | October 23, 1987 |
| K873126 | SODIUM/POTASSIUM REAGENT KIT | October 23, 1987 |
| K873131 | CREATININE REAGENT KIT | October 23, 1987 |
| K873128 | GLUCOSE REAGENT KIT | October 23, 1987 |
| K873127 | CHLORIDE REAGENT KIT | October 23, 1987 |
| K873132 | BUN REAGENT KIT | October 23, 1987 |
| K873129 | CARBON DIOXIDE REAGENT KIT | October 23, 1987 |