ACS CKMB II IMMUNOASSAY— 510(k) K962126
Substantially EquivalentCiba Corning Diagnostics Corp.
FDA 510(k) clearance K962126 for ACS CKMB II IMMUNOASSAY, Substantially Equivalent on 1996-06-21. Applicant: Ciba Corning Diagnostics Corp.. Device class: 2.
Clearance details
- Applicant
- Ciba Corning Diagnostics Corp.
- Product code
- Code JHS
- Device class
- Class 2
- Regulation
- 21 CFR 862.1215
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code JHS
view allMore clearances from Ciba Corning Diagnostics Corp.
view allRecalls naming K962126
K-number listed on FDA's recall record- Z-0113-2019 — ADVIA Centaur CKMB Calibrator, Cat No. 09318028 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.
- Z-0114-2019 — ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.
- Z-0115-2019 — ADVIA Centaur CKMB Master Curve Material, Cat No. 07867768 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
- Z-0116-2019 — Atellica IM CKMB Calibrator, Cat No. 10995532 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
- Z-0117-2019 — Atellica IM CKMB Master Curve Material, Cat No. 10995534 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K962126.
Data sourced from openFDA. This site is unofficial and independent of the FDA.