The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Immulite 2000 3gallergy Specific Ige Assay Kit.
| Device ID | K112523 |
| 510k Number | K112523 |
| Device Name: | IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | Garo Mimaryan |
| Correspondent | Garo Mimaryan Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Product Code | DHB |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-31 |
| Decision Date | 2012-01-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414988160 | K112523 | 000 |
| 00630414988153 | K112523 | 000 |
| 00630414988146 | K112523 | 000 |
| 00630414988122 | K112523 | 000 |
| 00630414982915 | K112523 | 000 |