OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071— 510(k) K043460
Substantially EquivalentOlympus America, Inc.
FDA 510(k) clearance K043460 for OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071, Substantially Equivalent on 2005-01-31. Applicant: Olympus America, Inc.. Device class: 2.
Clearance details
- Applicant
- Olympus America, Inc.
- Product code
- Code JIX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Irving, TX, US
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More clearances from Olympus America, Inc.
view allRecalls naming K043460
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 K043460.
Data sourced from openFDA. This site is unofficial and independent of the FDA.