Company ยท US
Genchem, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2009. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 5, 2009 | K090283 | CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3 Genchem, Inc. | JIX |
| Dec 27, 2004 | K040977 | GENCHEM ELECTROLYTE BUFFER Genchem, Inc. | JGS |
| Dec 27, 2004 | K040976 | GENCHEM CREATININE REAGENT Genchem, Inc. | CGX |
| Dec 27, 2004 | K040975 | GENCHEM CO2 ACID REAGENT Genchem, Inc. | JFL |
| Dec 27, 2004 | K040974 | GLUCOSE OXIDASE, GLUCOSE Genchem, Inc. | CGA |
| Dec 27, 2004 | K040973 | BUN REAGENT Genchem, Inc. | CDS |
| Dec 27, 2004 | K040972 | CALCIUM, AZO DYE REAGENT Genchem, Inc. | CJY |
| Dec 22, 2004 | K040971 | GENCHEM ISE ELECTROLYTE REFERENCE Genchem, Inc. | JGS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||