Genchem, Inc.
Genchem, Inc. appears in FDA public data with 0 recalls, 8 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on June 5, 2009.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 8
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K090283 | CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3 | June 5, 2009 |
| K040975 | GENCHEM CO2 ACID REAGENT | December 27, 2004 |
| K040976 | GENCHEM CREATININE REAGENT | December 27, 2004 |
| K040972 | CALCIUM, AZO DYE REAGENT | December 27, 2004 |
| K040973 | BUN REAGENT | December 27, 2004 |
| K040974 | GLUCOSE OXIDASE, GLUCOSE | December 27, 2004 |
| K040977 | GENCHEM ELECTROLYTE BUFFER | December 27, 2004 |
| K040971 | GENCHEM ISE ELECTROLYTE REFERENCE | December 22, 2004 |