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 |