KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (THEO)— 510(k) K861367
Substantially EquivalentEastman Kodak Company
FDA 510(k) clearance K861367 for KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (THEO), Substantially Equivalent on 1986-05-29. Applicant: Eastman Kodak Company. Device class: 2.
Clearance details
- Applicant
- Eastman Kodak Company
- Product code
- Code KLS
- Device class
- Class 2
- Regulation
- 21 CFR 862.3880
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
Recent devices under product code KLS
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view allRecalls naming K861367
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 K861367.
Data sourced from openFDA. This site is unofficial and independent of the FDA.