The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Immulite 2000 Systems 3gallergy Specific Ige Assay.
| Device ID | K132801 |
| 510k Number | K132801 |
| Device Name: | IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | Ernest Joseph |
| Correspondent | Ernest Joseph 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 | 2013-09-13 |
| Decision Date | 2014-05-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414006345 | K132801 | 000 |
| 00630414006291 | K132801 | 000 |
| 00630414006284 | K132801 | 000 |
| 00630414006277 | K132801 | 000 |
| 00630414006253 | K132801 | 000 |
| 00630414006246 | K132801 | 000 |
| 00630414000138 | K132801 | 000 |