FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MONOJECT SAMPLETTE AMBER CAPILLARY SERUM SEPARATOR
K Number: K875061
·
Decision Jan 12, 1988
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
21
Applicant Total
191
Review Days
34
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Basic Information
- Device Name
- MONOJECT SAMPLETTE AMBER CAPILLARY SERUM SEPARATOR
- K Number
- K875061
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.6150
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Sherwood Medical Co.
- Date Received
- December 9, 1987
- Decision Date
- January 12, 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 Sherwood Medical Co.
| K Number | Device Name | ||
|---|---|---|---|
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| K960574 | ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEM | Aug 5, 1996 | Substantially Equivalent |
| K960677 | KANGAROO JEJUNAL FEEDING SYSTEM | May 13, 1996 | Substantially Equivalent |
| K960632 | KANGAROO FEEDING TUBE PLACMENT STYLET | May 9, 1996 | Substantially Equivalent |
| K955831 | ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM | Mar 28, 1996 | Substantially Equivalent |
| K954429 | KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT | Mar 8, 1996 | Unknown |
| K954525 | SENSI-TOUCH EPIDURAL ANESTHESIA FILTER | Jan 19, 1996 | Substantially Equivalent |
| K950201 | ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER | Dec 15, 1995 | Substantially Equivalent |