FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OLYMPUS ACID PHOSPHATASE REAGENT
K Number: K963640
·
Decision Feb 18, 1997
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
23
Applicant Total
149
Review Days
159
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Basic Information
- Device Name
- OLYMPUS ACID PHOSPHATASE REAGENT
- K Number
- K963640
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1020
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Olympus America, Inc.
- Date Received
- September 12, 1996
- Decision Date
- February 18, 1997
- Product Code
- CKB
- 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 |
|---|---|---|---|
| CKB | Acid Phosphatase, Naphthyl Phosphate | FDA class 2 | Clinical Chemistry |
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