The following data is part of a premarket notification filed by Data Medical Associates, Inc. with the FDA for Total Bilirubin Procedure.
| Device ID | K955300 |
| 510k Number | K955300 |
| Device Name: | TOTAL BILIRUBIN PROCEDURE |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington, TX 76011 |
| Contact | C. H. Morris |
| Correspondent | C. H. Morris 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 | 1995-11-20 |
| Decision Date | 1995-12-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845275001068 | K955300 | 000 |