FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CHEMPRO 1000(TM)
K Number: K870860
·
Decision Apr 14, 1987
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
14
Applicant Total
3
Review Days
42
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Basic Information
- Device Name
- CHEMPRO 1000(TM)
- K Number
- K870860
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5600
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Arden Medical Systems, Inc.
- Date Received
- March 3, 1987
- Decision Date
- April 14, 1987
- Product Code
- GKF
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| GKF | Instrument, Hematocrit, Automated | FDA class 2 | Hematology |
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