The following data is part of a premarket notification filed by Crestat Diagnostics, Inc. with the FDA for N-assay Tia Microalbumin Calibrator Set.
| Device ID | K934143 |
| 510k Number | K934143 |
| Device Name: | N-ASSAY TIA MICROALBUMIN CALIBRATOR SET |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | CRESTAT DIAGNOSTICS, INC. 31360 VIA COLINAS SUITE 106 Westlake Village, CA 91362 |
| Contact | Mary Rees |
| Correspondent | Mary Rees CRESTAT DIAGNOSTICS, INC. 31360 VIA COLINAS SUITE 106 Westlake Village, CA 91362 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-24 |
| Decision Date | 1993-11-05 |