Neogenex
Everett, WA, US
Neogenex appears in FDA device records in Everett, WA. FDA records list 20 510(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
- 20
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 20 510(k) clearances for Neogenex between 1994 and 1997. The busiest year on record is 1994, with 18. The most recent is 1997, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 18 |
| 1996 | 1 |
| 1997 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K965047 | MINK LUNG CELL CULTURE | KIR | Substantially Equivalent | |
| K960909 | H292 CELL CULTURE | KIR | Substantially Equivalent | |
| K943891 | RD CULTURE CELL | KIR | Substantially Equivalent | |
| K943890 | WI38 CELL CULTURE | KIR | Substantially Equivalent | |
| K943889 | VERO CELL CULTURE | KIR | Substantially Equivalent | |
| K943888 | MDCK CELL CULTURE | KIR | Substantially Equivalent | |
| K943887 | HUMAN NEWBORN FORESKIN CELL CULTURE | KIR | Substantially Equivalent | |
| K943886 | BGM CELL CULTURE | KIR | Substantially Equivalent | |
| K943885 | PRIMARY RABBIT KIDNEY CELL CULTURE | KIR | Substantially Equivalent | |
| K943884 | PRIMARY MONKEY KIDNEY CELL CULTURE | KIR | Substantially Equivalent | |
| K941714 | CHLAMYDIA TRACHOMATIS ANTIGEN TEST | LJP | Substantially Equivalent | |
| K942172 | INFLUENZA A ANTIGEN TEST | GNW | Substantially Equivalent | |
| K942174 | INFLUENZA B ANITGEN TEST | GNW | Substantially Equivalent | |
| K942173 | RSV ANTIGEN TEST | LKT | Substantially Equivalent | |
| K942171 | CMV EARLY ANTIGEN TEST | GQI | Substantially Equivalent | |
| K933927 | HEP-2 CULTURE CELL | KIR | Substantially Equivalent | |
| K933926 | LLCMK2 CULTURE CELLS | KIR | Substantially Equivalent | |
| K933925 | MRC-5 CULTURE CELL | KIR | Substantially Equivalent | |
| K933924 | MCCOY CULTURE CELL | KIR | Substantially Equivalent | |
| K933923 | A549 CULTURE CELL | KIR | 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