FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
THE CEN-SLIDE(TM) CENTRIFUGE TUBE
K Number: K891604
·
Decision Jun 16, 1989
Classifications
1
FEI Numbers
105
Registration Numbers
105
Same Product Code
7
Applicant Total
1
Review Days
88
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Basic Information
- Device Name
- THE CEN-SLIDE(TM) CENTRIFUGE TUBE
- K Number
- K891604
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.3010
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Davstar California, Inc.
- Date Received
- March 20, 1989
- Decision Date
- June 16, 1989
- Product Code
- KEW
- Advisory Committee
- Pathology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| KEW | Slides, Microscope | FDA class 1 | Pathology |
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