The following data is part of a premarket notification filed by Data Medical Associates, Inc. with the FDA for Total Bilirubin Standards.
| Device ID | K852068 |
| 510k Number | K852068 |
| Device Name: | TOTAL BILIRUBIN STANDARDS |
| Classification | Calibrator, Primary |
| Applicant | DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington, TX 76011 |
| Contact | Jerry A Graham |
| Correspondent | Jerry A Graham DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington, TX 76011 |
| Product Code | JIS |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-10 |
| Decision Date | 1985-05-31 |