The following data is part of a premarket notification filed by Siemens Medical Solutions Diagnostics with the FDA for Immulite 2000 3gallergy Specific Ige Assay Kit, Model L2kun6.
| Device ID | K100910 |
| 510k Number | K100910 |
| Device Name: | IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5210 PACIFIC CONCOURSE DR. Los Angeles, CA 90045 -6900 |
| Contact | Donna Velasquez |
| Correspondent | Donna Velasquez SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5210 PACIFIC CONCOURSE DR. Los Angeles, CA 90045 -6900 |
| Product Code | DHB |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-01 |
| Decision Date | 2011-05-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414996394 | K100910 | 000 |
| 00630414973203 | K100910 | 000 |
| 00630414973289 | K100910 | 000 |
| 00630414978543 | K100910 | 000 |
| 00630414978611 | K100910 | 000 |
| 00630414978666 | K100910 | 000 |
| 00630414996257 | K100910 | 000 |
| 00630414996288 | K100910 | 000 |
| 00630414996318 | K100910 | 000 |
| 00630414972527 | K100910 | 000 |