The following data is part of a premarket notification filed by Data Medical Associates, Inc. with the FDA for Direct Bilirubin Procedure Run On A Au5000 Instru..
| Device ID | K880397 |
| 510k Number | K880397 |
| Device Name: | DIRECT BILIRUBIN PROCEDURE RUN ON A AU5000 INSTRU. |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington, TX 76011 |
| Contact | Marjorie B Potts |
| Correspondent | Marjorie B Potts DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington, TX 76011 |
| Product Code | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-29 |
| Decision Date | 1988-03-15 |