The following data is part of a premarket notification filed by Ark Diagnostics,inc with the FDA for Ark Methotrexate Assay, Ark Methotrexate Calibrator, Ark Methotrexate Control, Ark Methotrexate Control (calibration Ran.
| Device ID | K111904 |
| 510k Number | K111904 |
| Device Name: | ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN |
| Classification | Enzyme Immunoassay, Methotrexate |
| Applicant | ARK DIAGNOSTICS,INC 1190 BORDEAUX DRIVE Sunnyvale, CA 94089 |
| Contact | Kenneth C Kasper |
| Correspondent | Kenneth C Kasper ARK DIAGNOSTICS,INC 1190 BORDEAUX DRIVE Sunnyvale, CA 94089 |
| Product Code | LAO |
| Subsequent Product Code | DLJ |
| Subsequent Product Code | LAS |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-05 |
| Decision Date | 2011-10-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858724003391 | K111904 | 000 |
| 00858724003056 | K111904 | 000 |
| 00858724003117 | K111904 | 000 |
| 00858724003179 | K111904 | 000 |
| 00858724003186 | K111904 | 000 |
| 00858724003193 | K111904 | 000 |
| 00858724003209 | K111904 | 000 |
| 00858724003216 | K111904 | 000 |
| 00858724003254 | K111904 | 000 |
| 00812101030639 | K111904 | 000 |