Diatek, Inc.
Winston-Salem, NC, US
Diatek, Inc. appears in FDA device records in Winston-Salem, NC. FDA records list 15 510(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
- 15
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 15 510(k) clearances for Diatek, Inc. between 1979 and 2002. The busiest year on record is 1983, with 4. The most recent is 2002, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1981 | 1 |
| 1982 | 1 |
| 1983 | 4 |
| 1984 | 3 |
| 1987 | 1 |
| 1988 | 1 |
| 1989 | 1 |
| 2001 | 1 |
| 2002 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K020430 | DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK) | NFK | Substantially Equivalent | |
| K010399 | DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM) | MSD | Substantially Equivalent | |
| K895703 | DIATEK MODEL 700 THERMOMETER | FLL | Substantially Equivalent | |
| K872178 | MODIFICATION TO ARKIVE(TM) | BSZ | Substantially Equivalent | |
| K862085 | ARKIVE (TM) | BSZ | Substantially Equivalent | |
| K841827 | ENTEROPORT NUTRITION PUMP | FRN | Substantially Equivalent | |
| K841859 | SECURA SET | FPA | Substantially Equivalent | |
| K833568 | DIATEK 600 THERMOMETER SYSTEM | FLL | Substantially Equivalent | |
| K830565 | SECURA SET SECONDARY ADMIN. SET | FPA | Substantially Equivalent | |
| K830377 | SECURA SET PRIMARY ADMIN. SET | FPA | Substantially Equivalent | |
| K830355 | SECURA IV VOLUMETRIC INFUSION PUMP | FRN | Substantially Equivalent | |
| K830448 | SECURA SET VOLUME LIMITING SET | FPA | Substantially Equivalent | |
| K813468 | ACC-U-THERM TEMPERATURE MONITOR | FLL | Substantially Equivalent | |
| K810575 | MARTIN TRACH-SECURE | BTO | Substantially Equivalent | |
| K790416 | DIATEK 500 | FLL | 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