FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AUTOLET
K Number: K801815
·
Decision Oct 10, 1980
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
6
Applicant Total
20
Review Days
72
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Basic Information
- Device Name
- AUTOLET
- K Number
- K801815
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.6100
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Ulster Scientific, Inc.
- Date Received
- July 30, 1980
- Decision Date
- October 10, 1980
- Product Code
- JCA
- 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 |
|---|---|---|---|
| JCA | Device, Bleeding Time | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JCA), ordered by most recent decision date.
SIMPLATE PEDIATRIC
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SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION
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Q.I.C. BLEEDING TIME DEVICE
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SURGICUTT - BLEEDING TIME DEVICE
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BLEEDING TIME DEVICE DISPOSABLE
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SIMPLATE
FDA 510(k)
FDA Class 2
·Hematology
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|---|---|---|---|
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| 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 |