FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OLYMPUS CK-MB REAGENT
K Number: K971817
·
Decision Jun 11, 1997
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
2
Applicant Total
145
Review Days
26
Basic Information
- Device Name
- OLYMPUS CK-MB REAGENT
- K Number
- K971817
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1210
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- OLYMPUS AMERICA, INC.
- Date Received
- May 16, 1997
- Decision Date
- June 11, 1997
- Product Code
- JLB
- 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 |
|---|---|---|---|
| JLB | Atp And Creatine Kinase (Enzymatic), Creatine | FDA class 1 | Clinical Chemistry |
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