The following data is part of a premarket notification filed by American Diagnostic Corp. with the FDA for Coagulation Reference Plasma, Normal.
| Device ID | K932145 |
| 510k Number | K932145 |
| Device Name: | COAGULATION REFERENCE PLASMA, NORMAL |
| Classification | Plasma, Control, Normal |
| Applicant | AMERICAN DIAGNOSTIC CORP. 222 RAILROAD AVE. P.O. BOX 1165 Greenwich, CT 06836 |
| Contact | Vincent Forte |
| Correspondent | Vincent Forte AMERICAN DIAGNOSTIC CORP. 222 RAILROAD AVE. P.O. BOX 1165 Greenwich, CT 06836 |
| Product Code | GIZ |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-04 |
| Decision Date | 1993-10-18 |