The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Immulite 2000 3gallergy Specific Ige Assay Kit.
| Device ID | K083314 |
| 510k Number | K083314 |
| Device Name: | IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 511 Benedict Avenue Tarrytown, NY 10591 |
| Contact | Clare Santulli |
| Correspondent | Clare Santulli SIEMENS HEALTHCARE DIAGNOSTICS 511 Benedict Avenue 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 | 2008-11-10 |
| Decision Date | 2009-03-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414995878 | K083314 | 000 |
| 00630414979199 | K083314 | 000 |
| 00630414979021 | K083314 | 000 |
| 00630414978956 | K083314 | 000 |
| 00630414978925 | K083314 | 000 |
| 00630414973371 | K083314 | 000 |