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 | K091984 |
| 510k Number | K091984 |
| 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 | Clare Santulli |
| Correspondent | Clare Santulli 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 | 2009-07-02 |
| Decision Date | 2009-10-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414996509 | K091984 | 000 |
| 00630414973265 | K091984 | 000 |
| 00630414973241 | K091984 | 000 |
| 00630414973227 | K091984 | 000 |
| 00630414972619 | K091984 | 000 |
| 00630414965598 | K091984 | 000 |
| 00630414965567 | K091984 | 000 |
| 00630414960340 | K091984 | 000 |
| 00630414960302 | K091984 | 000 |
| 00630414960272 | K091984 | 000 |
| 00630414960043 | K091984 | 000 |
| 00630414960005 | K091984 | 000 |
| 00630414973319 | K091984 | 000 |
| 00630414973401 | K091984 | 000 |
| 00630414973425 | K091984 | 000 |
| 00630414996493 | K091984 | 000 |
| 00630414996486 | K091984 | 000 |
| 00630414996479 | K091984 | 000 |
| 00630414996417 | K091984 | 000 |
| 00630414996387 | K091984 | 000 |
| 00630414996349 | K091984 | 000 |
| 00630414978628 | K091984 | 000 |
| 00630414978604 | K091984 | 000 |
| 00630414978468 | K091984 | 000 |
| 00630414973500 | K091984 | 000 |
| 00630414973494 | K091984 | 000 |
| 00630414959887 | K091984 | 000 |