EKTACHEM CLINICAL CHEMISTRY CALCIUM (CA) SLIDE— 510(k) K961226
Substantially EquivalentJohnson & Johnson Clinical Diagnostics, Inc.
FDA 510(k) clearance K961226 for EKTACHEM CLINICAL CHEMISTRY CALCIUM (CA) SLIDE, Substantially Equivalent on 1996-05-07. Applicant: Johnson & Johnson Clinical Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Johnson & Johnson Clinical Diagnostics, Inc.
- Product code
- Code CJY
- Device class
- Class 2
- Regulation
- 21 CFR 862.1145
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
Recent devices under product code CJY
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Recalls naming K961226
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 K961226.
Data sourced from openFDA. This site is unofficial and independent of the FDA.