The following data is part of a premarket notification filed by Cirrus Diagnostics, Inc. with the FDA for Immulite Digoxin.
| Device ID | K914833 |
| 510k Number | K914833 |
| Device Name: | IMMULITE DIGOXIN |
| Classification | Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Coated Tube Sep. |
| Applicant | CIRRUS DIAGNOSTICS, INC. P.O. BOX 15 Chester, NJ 07930 |
| Contact | M.di Tullio |
| Correspondent | M.di Tullio CIRRUS DIAGNOSTICS, INC. P.O. BOX 15 Chester, NJ 07930 |
| Product Code | DPO |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-25 |
| Decision Date | 1991-11-22 |