FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117
K Number: K061575
·
Decision Oct 5, 2006
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
46
Applicant Total
149
Review Days
120
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Basic Information
- Device Name
- OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117
- K Number
- K061575
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1145
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Olympus America, Inc.
- Date Received
- June 7, 2006
- Decision Date
- October 5, 2006
- Product Code
- CJY
- 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 |
|---|---|---|---|
| CJY | Azo Dye, Calcium | FDA class 2 | Clinical Chemistry |
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| K060201 | OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105. | Jun 6, 2006 | Substantially Equivalent |