ACS CORTISOL IMMUNOASSAY— 510(k) K962559
Substantially EquivalentCiba Corning Diagnostics Corp.
FDA 510(k) clearance K962559 for ACS CORTISOL IMMUNOASSAY, Substantially Equivalent on 1996-11-05. Applicant: Ciba Corning Diagnostics Corp.. Device class: 2.
Clearance details
- Applicant
- Ciba Corning Diagnostics Corp.
- Product code
- Code JFT
- Device class
- Class 2
- Regulation
- 21 CFR 862.1205
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code JFT
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view allRecalls naming K962559
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K962559.
Data sourced from openFDA. This site is unofficial and independent of the FDA.