FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OLYMPUS URIC ACID REAGENT, MODEL OSR6X98
K Number: K062862
·
Decision Apr 6, 2007
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
117
Applicant Total
149
Review Days
193
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Basic Information
- Device Name
- OLYMPUS URIC ACID REAGENT, MODEL OSR6X98
- K Number
- K062862
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1775
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Olympus America, Inc.
- Date Received
- September 25, 2006
- Decision Date
- April 6, 2007
- Product Code
- KNK
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KNK | Acid, Uric, Uricase (Colorimetric) | FDA class 1 | Clinical Chemistry |
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Other Clearances by Olympus America, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K111788 | ENDOEYE HD II | Jan 13, 2012 | Substantially Equivalent |
| K081615 | OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN | Mar 18, 2009 | Substantially Equivalent |
| K073487 | OLYMPUS IGM REAGENT | Feb 11, 2008 | Substantially Equivalent |
| K073490 | OLYMPUS IGG REAGENT | Feb 11, 2008 | Substantially Equivalent |
| K073489 | OLYMPUS IGA REAGENT | Feb 11, 2008 | Substantially Equivalent |
| K063804 | OLYMPUS TRIGLYCERIDE TEST SYSTEM | Mar 23, 2007 | Substantially Equivalent |
| K061499 | OSFERION | Jan 26, 2007 | Substantially Equivalent |
| K062581 | OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM | Nov 29, 2006 | Substantially Equivalent |
| K061575 | OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117 | Oct 5, 2006 | Substantially Equivalent |
| K060201 | OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105. | Jun 6, 2006 | Substantially Equivalent |