The following data is part of a premarket notification filed by American Diagnostic Corp. with the FDA for Rellplate C Kit, Rellplate C Bulk Plates.
| Device ID | K884940 |
| 510k Number | K884940 |
| Device Name: | RELLPLATE C KIT, RELLPLATE C BULK PLATES |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| Applicant | AMERICAN DIAGNOSTIC CORP. 49 EAST 68TH ST. New York, NY 10021 |
| Contact | Hart, Ph.d. |
| Correspondent | Hart, Ph.d. AMERICAN DIAGNOSTIC CORP. 49 EAST 68TH ST. New York, NY 10021 |
| Product Code | GGP |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-28 |
| Decision Date | 1989-03-13 |