The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immunlite 2000 Allergen-specific Ige And Mixed Allergen Panels, Model L2kun6 (600 Tests).
| Device ID | K013135 |
| 510k Number | K013135 |
| Device Name: | IMMUNLITE 2000 ALLERGEN-SPECIFIC IGE AND MIXED ALLERGEN PANELS, MODEL L2KUN6 (600 TESTS) |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| 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 | DHB |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-19 |
| Decision Date | 2001-10-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414965529 | K013135 | 000 |
| 00630414960371 | K013135 | 000 |
| 00630414960401 | K013135 | 000 |
| 00630414960432 | K013135 | 000 |
| 00630414960609 | K013135 | 000 |
| 00630414960623 | K013135 | 000 |
| 00630414960678 | K013135 | 000 |
| 00630414965086 | K013135 | 000 |
| 00630414965352 | K013135 | 000 |
| 00630414965376 | K013135 | 000 |
| 00630414965505 | K013135 | 000 |
| 00630414959856 | K013135 | 000 |