The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for N Antisera To Human Immunoglobulins (igg, Iga And Igm) And N/t Protein Control Lc.
| Device ID | K083445 |
| 510k Number | K083445 |
| Device Name: | N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN CONTROL LC |
| Classification | Method, Nephelometric, Immunoglobulins (g, A, M) |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE M/S 514 Newark, DE 19714 |
| Contact | Helen M Lee |
| Correspondent | Helen M Lee SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE M/S 514 Newark, DE 19714 |
| Product Code | CFN |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-21 |
| Decision Date | 2009-03-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768009808 | K083445 | 000 |
| 00842768009785 | K083445 | 000 |
| 00842768007859 | K083445 | 000 |