The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Cea.
| Device ID | K970877 |
| 510k Number | K970877 |
| Device Name: | IMMULITE CEA |
| Classification | System, Test, Carcinoembryonic Antigen |
| Applicant | DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Contact | Edward M Levine |
| Correspondent | Edward M Levine DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Product Code | DHX |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-10 |
| Decision Date | 1997-09-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414963693 | K970877 | 000 |
| 00630414953625 | K970877 | 000 |