FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OLYMPUS CALCIUM ARSENAZO III REAGENT
K Number: K982035
·
Decision Jun 24, 1998
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
46
Applicant Total
4
Review Days
14
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Basic Information
- Device Name
- OLYMPUS CALCIUM ARSENAZO III REAGENT
- K Number
- K982035
- 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 Diagnostica GmbH
- Date Received
- June 10, 1998
- Decision Date
- June 24, 1998
- 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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