The following data is part of a premarket notification filed by American Diagnostica, Inc. with the FDA for Dvvtest And Dvvconfirm Lupus Anticoagulant Normal And Abnormal Control Plasma.
| Device ID | K935254 |
| 510k Number | K935254 |
| Device Name: | DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA |
| Classification | Plasma, Control, Normal |
| Applicant | AMERICAN DIAGNOSTICA, INC. 222 RAILROAD AVE. P.O. BOX 1165 Greenwich, CT 06836 -1165 |
| Contact | Richard Hart |
| Correspondent | Richard Hart AMERICAN DIAGNOSTICA, INC. 222 RAILROAD AVE. P.O. BOX 1165 Greenwich, CT 06836 -1165 |
| Product Code | GIZ |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-01 |
| Decision Date | 1994-09-19 |