The following data is part of a premarket notification filed by Data Medical Associates, Inc. with the FDA for Iron Calibrator & Calibration Verification Set.
| Device ID | K955796 |
| 510k Number | K955796 |
| Device Name: | IRON CALIBRATOR & CALIBRATION VERIFICATION SET |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| 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 | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-22 |
| Decision Date | 1996-02-29 |