CIBA CORNING MAGIC(R) LITE CKMB IMMUNOASSAY— 510(k) K870987

Substantially Equivalent

Ciba Corning Diagnostics Corp.

FDA 510(k) clearance K870987 for CIBA CORNING MAGIC(R) LITE CKMB IMMUNOASSAY, Substantially Equivalent on 1987-05-26. Applicant: Ciba Corning Diagnostics Corp.. Device class: 2.

Clearance details

Applicant
Ciba Corning Diagnostics Corp.
Product code
Code JHX
Device class
Class 2
Regulation
21 CFR 862.1215
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
East Walpole, MA, US
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