The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Immulite 2000; Cortisol Calibration Verification Material, Folic Acid Calibration Verification Material, Vitamin B12 Cal.
| Device ID | K141444 |
| 510k Number | K141444 |
| Device Name: | IMMULITE 2000; CORTISOL CALIBRATION VERIFICATION MATERIAL, FOLIC ACID CALIBRATION VERIFICATION MATERIAL, VITAMIN B12 CAL |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | Siemens Healthcare Diagnostics Inc. 5210 PACIFIC CONCOURSE DRIVE Los Angeles, CA 90045 |
| Contact | Donna Velasquez |
| Correspondent | Donna Velasquez Siemens Healthcare Diagnostics Inc. 5210 PACIFIC CONCOURSE DRIVE Los Angeles, CA 90045 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-02 |
| Decision Date | 2014-07-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414977485 | K141444 | 000 |
| 00630414971421 | K141444 | 000 |
| 00630414971230 | K141444 | 000 |