FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SEROJET
K Number: K003908
·
Decision Mar 8, 2001
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
52
Applicant Total
9
Review Days
79
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Basic Information
- Device Name
- SEROJET
- K Number
- K003908
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5430
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bioject, Inc.
- Date Received
- December 19, 2000
- Decision Date
- March 8, 2001
- Product Code
- KZE
- 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 |
|---|---|---|---|
| KZE | Injector, Fluid, Non-Electrically Powered | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KZE), ordered by most recent decision date.
BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
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PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI
FDA 510(k)
FDA Class 2
·General Hospital
PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA
FDA 510(k)
FDA Class 2
·General Hospital
ZETAJET
FDA 510(k)
FDA Class 2
·General Hospital
PHARMAJET NEEDLE-FREE INJECTION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Bioject, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K090003 | ZETAJET | Apr 2, 2009 | Substantially Equivalent |
| K050734 | COOL.CLICK | Jun 3, 2005 | Substantially Equivalent |
| K010623 | RECONSTITUTION KIT & VIAL CONNECTOR | Apr 5, 2001 | Substantially Equivalent |
| K994384 | CLICKER | Jun 22, 2000 | Substantially Equivalent |
| K960373 | BIOJECTOR 2000 MODEL 1B02000 | Mar 5, 1997 | Substantially Equivalent |
| K963012 | BIOJECT NEEDLE-FREE VIAL ADAPTER (13MM) | Oct 15, 1996 | Substantially Equivalent |
| K920631 | BIOJECT JET INJECTION SYSTEM | Jun 28, 1994 | Substantially Equivalent |
| K861687 | BIOJECTOR SYRINGE SYSTEM | Apr 23, 1987 | Substantially Equivalent |