ENZYME II CALIBRATOR— 510(k) K103836
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K103836 for ENZYME II CALIBRATOR, Substantially Equivalent on 2011-02-16. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Product code
- Code JIT
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newark, DE, US
Recent devices under product code JIT
view allMore clearances from Siemens Healthcare Diagnostics, Inc.
view allRecalls naming K103836
K-number listed on FDA's recall record- Z-1712-2017 — ADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture Product Usage: Assays included in Enzyme 2 Calibrator: AST, AST_c ALT, ALT_c, ALTP5P, ALTP_c, ASTP5P and ASTP_c
- Z-1217-2017 — The Enzyme II Calibrator is an in vitro diagnostic product for the Alanine Aminotransferase (ALTI) on the Dimension¿ clinical chemistry system. For prescription use only.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K103836.
Data sourced from openFDA. This site is unofficial and independent of the FDA.