FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEONATAL UNILET
K Number: K861243
·
Decision Apr 29, 1986
Classifications
1
FEI Numbers
157
Registration Numbers
157
Same Product Code
109
Applicant Total
20
Review Days
27
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Basic Information
- Device Name
- NEONATAL UNILET
- K Number
- K861243
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4850
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Ulster Scientific, Inc.
- Date Received
- April 2, 1986
- Decision Date
- April 29, 1986
- Product Code
- FMK
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Ulster Scientific, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K942620 | FEATHER-TOUCH SINGLE-STICK DEVICE | Jun 22, 1994 | Substantially Equivalent |
| K920562 | UNISTIK | Mar 27, 1992 | Substantially Equivalent |
| K902592 | EPC ELECTRONIC PIPETTING SYSTEM | Jul 19, 1990 | Substantially Equivalent |
| K895890 | AUTOPEN | Feb 16, 1990 | Substantially Equivalent |
| K894474 | THE AUTOLET LITE | Aug 18, 1989 | Substantially Equivalent |
| K885340 | AIR DISPLACEMENT PIPETTE | Feb 14, 1989 | Substantially Equivalent |
| K875354 | UNISTEP CAPILLARY BLOOD COLLECTION SYSTEM | Feb 17, 1988 | Substantially Equivalent |
| K871571 | NEUROTIPS(TM) | Jun 18, 1987 | Substantially Equivalent |
| K871076 | WINPETTE | Mar 23, 1987 | Substantially Equivalent |
| K870078 | ACCUPEN(R) | Mar 17, 1987 | Substantially Equivalent |