FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
WINPETTE
K Number: K871076
·
Decision Mar 23, 1987
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
6
Applicant Total
20
Review Days
5
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Basic Information
- Device Name
- WINPETTE
- K Number
- K871076
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.6700
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Ulster Scientific, Inc.
- Date Received
- March 18, 1987
- Decision Date
- March 23, 1987
- Product Code
- JPH
- 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 |
|---|---|---|---|
| JPH | Test, Erythrocyte Sedimentation Rate | FDA class 1 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JPH), ordered by most recent decision date.
DISPETTE II
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SRT-SYSTEM
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FDA Class 1
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SEDIPLAST
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FDA Class 1
·Hematology
WESTERGREN DISPETTE FOR ESR
FDA 510(k)
FDA Class 1
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ERYTHROCYTE & STAND SEDIMENT. RATE TUBE
FDA 510(k)
FDA Class 1
·Hematology
DADE ESR KIT
FDA 510(k)
FDA Class 1
·Hematology
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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 |
| K870078 | ACCUPEN(R) | Mar 17, 1987 | Substantially Equivalent |
| K864761 | USI AUTOJECT INSULIN SYRINGE | Dec 16, 1986 | Substantially Equivalent |