FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CORNING BLOOD COLLECTION CAPILLARY TUBES
K Number: K850806
·
Decision Mar 25, 1985
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
21
Applicant Total
111
Review Days
26
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Basic Information
- Device Name
- CORNING BLOOD COLLECTION CAPILLARY TUBES
- K Number
- K850806
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.6150
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Corning Medical & Scientific
- Date Received
- February 27, 1985
- Decision Date
- March 25, 1985
- 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 |
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| K851329 | MAGIC MONOCLONAL ANTIBODY TSH(MAB TSH)RADIOIMMUNOA | Jun 13, 1985 | Substantially Equivalent |
| K850617 | CORNING 780 FLUOROMETER/DENSITOMETER | Mar 12, 1985 | Substantially Equivalent |
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