The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Immulite 2000 Cmv Igm, Immulite Cmv Igm Controls, And Immulite 200 Cmv Igm Adjustor Model L2kcm2, L2kcm6, Lcmc1, Lcmc2,.
| Device ID | K100433 |
| 510k Number | K100433 |
| Device Name: | IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2, |
| Classification | Antibody Igm,if, Cytomegalovirus Virus |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 1584 ENTERPRISE BLVD West Sacramento, CA 95691 |
| Contact | Robert C Eusebio |
| Correspondent | Robert C Eusebio SIEMENS HEALTHCARE DIAGNOSTICS 1584 ENTERPRISE BLVD West Sacramento, CA 95691 |
| Product Code | LKQ |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-16 |
| Decision Date | 2010-05-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414985725 | K100433 | 000 |
| 00630414985718 | K100433 | 000 |