The following data is part of a premarket notification filed by Cliniqa Corporation with the FDA for Olympus Urine Calibrator.
| Device ID | K033910 |
| 510k Number | K033910 |
| Device Name: | OLYMPUS URINE CALIBRATOR |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | CLINIQA CORPORATION 1432 SOUTH MISSION RD. Fallbrook, CA 92028 |
| Contact | Carol Ruggiero |
| Correspondent | Carol Ruggiero CLINIQA CORPORATION 1432 SOUTH MISSION RD. Fallbrook, CA 92028 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-17 |
| Decision Date | 2004-01-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590635565 | K033910 | 000 |
| 15099590635534 | K033910 | 000 |