The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Immulite 2000 Syphilis Screen Test System.
| Device ID | K091361 |
| 510k Number | K091361 |
| Device Name: | IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM |
| Classification | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 6695 RIVER CREST POINT Suwanee, GA 30024 |
| Contact | Carolyn K George |
| Correspondent | Carolyn K George SIEMENS HEALTHCARE DIAGNOSTICS 6695 RIVER CREST POINT Suwanee, GA 30024 |
| Product Code | LIP |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-08 |
| Decision Date | 2009-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414976891 | K091361 | 000 |
| 00630414976686 | K091361 | 000 |