FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GENESIS RMP
K Number: K963268
·
Decision Mar 18, 1997
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
0
Applicant Total
4
Review Days
210
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Basic Information
- Device Name
- GENESIS RMP
- K Number
- K963268
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2680
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Tecan U.S., Inc.
- Date Received
- August 20, 1996
- Decision Date
- March 18, 1997
- Product Code
- JRA
- 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 |
|---|---|---|---|
| JRA | Microtitrator, For Clinical Use | FDA class 1 | Clinical Chemistry |