The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite 2000 Mixed Allergen Panels.
| Device ID | K021208 |
| 510k Number | K021208 |
| Device Name: | IMMULITE 2000 MIXED ALLERGEN PANELS |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Contact | Robert M Di Tullio |
| Correspondent | Robert M Di Tullio 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-16 |
| Decision Date | 2002-05-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414996097 | K021208 | 000 |
| 00630414960456 | K021208 | 000 |
| 00630414960616 | K021208 | 000 |
| 00630414960630 | K021208 | 000 |
| 00630414965307 | K021208 | 000 |
| 00630414965314 | K021208 | 000 |
| 00630414965338 | K021208 | 000 |
| 00630414965369 | K021208 | 000 |
| 00630414965512 | K021208 | 000 |
| 00630414960418 | K021208 | 000 |