IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material
Single (specified) Analyte Controls (assayed And Unassayed)
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Immulite® 2000 Calcitonin Calibration Verification Material , Immulite® 2000 Prostatic Acid Phosphatase (pap) Calibration Verification Material.
Pre-market Notification Details
| Device ID | K143373 |
| 510k Number | K143373 |
| Device Name: | IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material |
| 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 | 2014-11-25 |
| Decision Date | 2015-02-26 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414971315 | K143373 | 000 |
| 00630414971186 | K143373 | 000 |
Trademark Results [IMMULITE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IMMULITE 74098401 1653588 Live/Registered |
SIEMENS HEALTHCARE DIAGNOSTICS INC. 1990-09-19 |
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