The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Immulite 2000 3g Allergy Specific Ige Assay Kit Model L2kun6.
| Device ID | K093987 |
| 510k Number | K093987 |
| Device Name: | IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY KIT MODEL L2KUN6 |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | Siemens Healthcare Diagnostics Inc. 5210 PACIFIC CONCOURSE DRIVE Los Angeles, CA 90045 |
| Contact | Donna Velasquez |
| Correspondent | Donna Velasquez Siemens Healthcare Diagnostics Inc. 5210 PACIFIC CONCOURSE DRIVE Los Angeles, CA 90045 |
| Product Code | DHB |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-24 |
| Decision Date | 2011-03-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414996578 | K093987 | 000 |
| 00630414970677 | K093987 | 000 |
| 00630414970660 | K093987 | 000 |
| 00630414970653 | K093987 | 000 |
| 00630414970646 | K093987 | 000 |
| 00630414970639 | K093987 | 000 |
| 00630414970622 | K093987 | 000 |
| 00630414959832 | K093987 | 000 |
| 00630414959795 | K093987 | 000 |
| 00630414970684 | K093987 | 000 |
| 00630414973487 | K093987 | 000 |
| 00630414975511 | K093987 | 000 |
| 00630414996547 | K093987 | 000 |
| 00630414996530 | K093987 | 000 |
| 00630414979175 | K093987 | 000 |
| 00630414979038 | K093987 | 000 |
| 00630414978994 | K093987 | 000 |
| 00630414978895 | K093987 | 000 |
| 00630414978833 | K093987 | 000 |
| 00630414978789 | K093987 | 000 |
| 00630414959702 | K093987 | 000 |