FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
REPLACEMENT REAGENTS FOR SMAC II SYSTEMS
K Number: K852306
·
Decision Aug 2, 1985
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
31
Applicant Total
1
Review Days
65
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Basic Information
- Device Name
- REPLACEMENT REAGENTS FOR SMAC II SYSTEMS
- K Number
- K852306
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Methodist Hospital of Memphis
- Date Received
- May 29, 1985
- Decision Date
- August 2, 1985
- Product Code
- JJC
- 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 |
|---|---|---|---|
| JJC | Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use | FDA class 1 | Clinical Chemistry |
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