The following data is part of a premarket notification filed by American Dade with the FDA for Paramax Urine/csf Calibrator.
| Device ID | K872789 |
| 510k Number | K872789 |
| Device Name: | PARAMAX URINE/CSF CALIBRATOR |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
| Contact | Krista U Smalley |
| Correspondent | Krista U Smalley AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-14 |
| Decision Date | 1987-09-02 |