The following data is part of a premarket notification filed by Data Medical Associates, Inc. with the FDA for Total Bilirubin Procedure Run On A Au5000 Instru..
Device ID | K880396 |
510k Number | K880396 |
Device Name: | TOTAL 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 |