FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIAMATIC, AUTOMATIC INSULIN INJECTOR
K Number: K860284
·
Decision Apr 7, 1986
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
46
Applicant Total
20
Review Days
69
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Basic Information
- Device Name
- DIAMATIC, AUTOMATIC INSULIN INJECTOR
- K Number
- K860284
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6920
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Ulster Scientific, Inc.
- Date Received
- January 28, 1986
- Decision Date
- April 7, 1986
- Product Code
- KZH
- 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 |
|---|---|---|---|
| KZH | Introducer, Syringe Needle | FDA class 2 | General Hospital |
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| 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 |