OLYMPUS URIC ACID REAGENT, MODEL OSR6X98— 510(k) K062862
Substantially EquivalentOlympus America, Inc.
FDA 510(k) clearance K062862 for OLYMPUS URIC ACID REAGENT, MODEL OSR6X98, Substantially Equivalent on 2007-04-06. Applicant: Olympus America, Inc.. Device class: 1.
Clearance details
- Applicant
- Olympus America, Inc.
- Product code
- Code KNK
- Device class
- Class 1
- Regulation
- 21 CFR 862.1775
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irving, TX, US
Recent devices under product code KNK
view allMore clearances from Olympus America, Inc.
view allRecalls naming K062862
K-number listed on FDA's recall record- Z-0211-2020 — Beckman Coulter Uric Acid, REF OSR6098, OSR6198, and OSR6698.
- Z-1932-2016 — Uric Acid, Catalog No. OSR6x98 Product Usage:Uric acid OSR6x98 is intended as a System reagent for the quantitative determination of Uric Acid in human serum, heparinized plasma and urine on Beckman Coulter AU analyzers.
- Z-1024-2015 — Beckman Coulter, Uric Acid Assay, Catalog No. OSR6X98
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K062862.
Data sourced from openFDA. This site is unofficial and independent of the FDA.