Infab, LLC.
Camarillo, CA, US
INFAB, LLC. appears in FDA device records in Camarillo, CA. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Infab, LLC. between 1989 and 1990. The busiest year on record is 1990, with 5. The most recent is 1990, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 1 |
| 1990 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K900972 | RADIATION PROTECTION GLOVES | IWP | Substantially Equivalent | |
| K900970 | RADIATION PROTECTION GLASSES | KPY | Substantially Equivalent | |
| K901014 | RADIOGRAPHIC INTENSIFYING SCREEN | EAM | Substantially Equivalent | |
| K901013 | RADIOGRAPHIC FILM CASSETTE | IXA | Substantially Equivalent | |
| K901012 | RADIOGRAPHIC GRID | IXJ | Substantially Equivalent | |
| K896289 | RADIATION PROTECTION APRON | KPY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2024351 | 2024351 | INFAB, LLC. | 1040 Avenida Acaso, CAMARILLO, CA 93012 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- EAJApron, Leaded
- IWOApron, Protective
- IXACassette, Radiographic Film
- FMRDevice, Transfer, Patient, Manual
- IXJGrid, Radiographic
- OEANon-Surgical Gown
- IWPRadiographic Protective Glove
- EAMScreen, Intensifying, Radiographic
- EAKScreen, Leaded, Operator Radiation Protector
- IWSShield, Eye, Radiological
- KPYShield, Protective, Personnel
- KGOSurgeon'S Gloves
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