FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
UNILET LANCET
K Number: K842517
·
Decision Sep 20, 1984
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
1
Applicant Total
20
Review Days
72
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Basic Information
- Device Name
- UNILET LANCET
- K Number
- K842517
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6140
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Ulster Scientific, Inc.
- Date Received
- July 10, 1984
- Decision Date
- September 20, 1984
- Product Code
- FML
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FML | Chair, Blood Donor | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FML), ordered by most recent decision date.
View allOther Clearances by Ulster Scientific, Inc.
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|---|---|---|---|
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| 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 |