FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ROSYS MODELS 100 AND 200
K Number: K913664
·
Decision Aug 30, 1991
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
139
Applicant Total
4
Review Days
14
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Basic Information
- Device Name
- ROSYS MODELS 100 AND 200
- K Number
- K913664
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2750
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Packard Instrument Co., Inc.
- Date Received
- August 16, 1991
- Decision Date
- August 30, 1991
- Product Code
- JQW
- 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 |
|---|---|---|---|
| JQW | Station, Pipetting And Diluting, For Clinical Use | FDA class 1 | Clinical Chemistry |
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