FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MODEL 4900 OFF-LINE PREPARATION SYSTEM
K Number: K801271
·
Decision Jun 9, 1980
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
139
Applicant Total
5
Review Days
12
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Basic Information
- Device Name
- MODEL 4900 OFF-LINE PREPARATION SYSTEM
- K Number
- K801271
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2750
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Pm America, Inc.
- Date Received
- May 28, 1980
- Decision Date
- June 9, 1980
- 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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