The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Br-ma, Model #lkbr; Immulite 2000 Br-ma, Model #l2kbr.
| Device ID | K013984 |
| 510k Number | K013984 |
| Device Name: | IMMULITE BR-MA, MODEL #LKBR; IMMULITE 2000 BR-MA, MODEL #L2KBR |
| Classification | System, Test, Immunological, Antigen, Tumor |
| 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 | MOI |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-03 |
| Decision Date | 2002-03-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414963655 | K013984 | 000 |
| 00630414961088 | K013984 | 000 |
| 00630414953601 | K013984 | 000 |