The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite 2000 Specific Allergens.
| Device ID | K021206 |
| 510k Number | K021206 |
| Device Name: | IMMULITE 2000 SPECIFIC ALLERGENS |
| 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 |
|---|---|---|
| 00630414996615 | K021206 | 000 |
| 00630414965970 | K021206 | 000 |
| 00630414965956 | K021206 | 000 |
| 00630414965642 | K021206 | 000 |
| 00630414965475 | K021206 | 000 |
| 00630414965444 | K021206 | 000 |
| 00630414965277 | K021206 | 000 |
| 00630414965024 | K021206 | 000 |
| 00630414960692 | K021206 | 000 |
| 00630414960586 | K021206 | 000 |
| 00630414960494 | K021206 | 000 |
| 00630414960173 | K021206 | 000 |
| 00630414959849 | K021206 | 000 |
| 00630414959801 | K021206 | 000 |
| 00630414973302 | K021206 | 000 |
| 00630414973524 | K021206 | 000 |
| 00630414975269 | K021206 | 000 |
| 00630414996608 | K021206 | 000 |
| 00630414996592 | K021206 | 000 |
| 00630414996585 | K021206 | 000 |
| 00630414996554 | K021206 | 000 |
| 00630414996134 | K021206 | 000 |
| 00630414996080 | K021206 | 000 |
| 00630414995953 | K021206 | 000 |
| 00630414995939 | K021206 | 000 |
| 00630414995885 | K021206 | 000 |
| 00630414995861 | K021206 | 000 |
| 00630414995847 | K021206 | 000 |
| 00630414979120 | K021206 | 000 |
| 00630414979076 | K021206 | 000 |
| 00630414959764 | K021206 | 000 |