Erika, Inc.
Walker, MI, US
Erika, Inc. appears in FDA device records in Walker, MI. FDA records list 12 510(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
- 12
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 12 510(k) clearances for Erika, Inc. between 1981 and 1984. The busiest year on record is 1982, with 5. The most recent is 1984, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 2 |
| 1982 | 5 |
| 1984 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K831176 | FILTRYZER HOLLOW FIBER ARTIF. KIDNEY | KOC | Substantially Equivalent | |
| K831175 | FILTRYZER HOLLOW FIBER ARTIF. KIDNEY | KOC | Substantially Equivalent | |
| K831174 | FILTRYZER HOLLOW FIBER ARTIFICIAL KID- | KOC | Substantially Equivalent | |
| K831173 | TORAY INDUSTRIES FILTRYZER HOLLOW FIBER | KOC | Substantially Equivalent | |
| K840859 | MAKS CENTRAL DELIVERY SYS-11-200 ETC | KOC | Substantially Equivalent | |
| K823115 | NATURALYTE BICARBONATE DIALYSATE 4400 | KRO | Substantially Equivalent | |
| K822796 | NEGATIVE PRESSURE ARTERIAL BLOOD LINE | KOC | Substantially Equivalent | |
| K822226 | ERIKA NEGATIVE PRESSURE VENOUS BLOOD LIN | KOC | Substantially Equivalent | |
| K822225 | ERIKA NEGAT. PRESSURE ARTER. BLOOD LINE | KOC | Substantially Equivalent | |
| K820179 | ERIKA CAPD PREP KIT #30-9501-5 | FKX | Substantially Equivalent | |
| K810824 | ERIKA HEPARIN INFUSION ADAPTOR | FJK | Substantially Equivalent | |
| K810823 | ERIKA EXTENSION SETS | FJK | 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