FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE
K Number: K884623
·
Decision Dec 1, 1988
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
21
Applicant Total
2
Review Days
27
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Basic Information
- Device Name
- SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE
- K Number
- K884623
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.6150
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Safe-Tec Clinical Products, Inc.
- Date Received
- November 4, 1988
- Decision Date
- December 1, 1988
- Product Code
- GIO
- 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 |
|---|---|---|---|
| GIO | Tube, Collection, Capillary Blood | FDA class 1 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GIO), ordered by most recent decision date.
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Other Clearances by Safe-Tec Clinical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K890109 | SAFEPETTE DISPENSER | Feb 23, 1989 | Substantially Equivalent |