The following data is part of a premarket notification filed by Data Medical Associates, Inc. with the FDA for Direct Biliruben Calibrations.
Device ID | K852067 |
510k Number | K852067 |
Device Name: | DIRECT BILIRUBEN CALIBRATIONS |
Classification | Calibrator, Secondary |
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 | JIT |
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 |