The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Immulite 2000 Androstenedione Calibration Verification Material, Immulite 2000 Troponin I Calibration Verification Material.
Device ID | K143636 |
510k Number | K143636 |
Device Name: | IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I 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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-12-22 |
Decision Date | 2015-02-25 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00630414978031 | K143636 | 000 |
00630414971391 | K143636 | 000 |