Genchem, Inc.
Brea, CA, US
Genchem, Inc. appears in FDA device records in Brea, CA. FDA records list 8 510(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
- 8
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 8 510(k) clearances for Genchem, Inc. between 2004 and 2009. The busiest year on record is 2004, with 7. The most recent is 2009, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 7 |
| 2009 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K090283 | CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3 | JIX | Substantially Equivalent | |
| K040977 | GENCHEM ELECTROLYTE BUFFER | JGS | Substantially Equivalent | |
| K040976 | GENCHEM CREATININE REAGENT | CGX | Substantially Equivalent | |
| K040975 | GENCHEM CO2 ACID REAGENT | JFL | Substantially Equivalent | |
| K040974 | GLUCOSE OXIDASE, GLUCOSE | CGA | Substantially Equivalent | |
| K040973 | BUN REAGENT | CDS | Substantially Equivalent | |
| K040972 | CALCIUM, AZO DYE REAGENT | CJY | Substantially Equivalent | |
| K040971 | GENCHEM ISE ELECTROLYTE REFERENCE | JGS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain