The following data is part of a premarket notification filed by Data Medical Associates, Inc. with the FDA for Hdl-c/ldl-c Calibrator, Model 1913-003.
| Device ID | K993098 |
| 510k Number | K993098 |
| Device Name: | HDL-C/LDL-C CALIBRATOR, MODEL 1913-003 |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington, TX 76011 |
| Contact | Thomas G Dollar |
| Correspondent | Thomas G Dollar DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington, TX 76011 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-16 |
| Decision Date | 1999-10-08 |
| Summary: | summary |