The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Digitoxin.
| Device ID | K943235 |
| 510k Number | K943235 |
| Device Name: | IMMULITE DIGITOXIN |
| Classification | Enzyme Immunoassay, Digitoxin |
| Applicant | DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Contact | Kenneth B Asarch |
| Correspondent | Kenneth B Asarch DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Product Code | LFM |
| CFR Regulation Number | 862.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-06 |
| Decision Date | 1994-10-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414963846 | K943235 | 000 |
| 00630414961262 | K943235 | 000 |