FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
U - STAR (MICRO-STAR)
K Number: K860703
·
Decision May 6, 1986
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
205
Applicant Total
8
Review Days
69
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Basic Information
- Device Name
- U - STAR (MICRO-STAR)
- K Number
- K860703
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Corning Costar Corp.
- Date Received
- February 26, 1986
- Decision Date
- May 6, 1986
- Product Code
- LHI
- 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 |
|---|---|---|---|
| LHI | Set, I.V. Fluid Transfer | FDA class 2 | General Hospital |
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Other Clearances by Corning Costar Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K871559 | CELL LIFTER | May 15, 1987 | Substantially Equivalent |
| K823137 | OCTAPETTES | Dec 3, 1982 | Substantially Equivalent |
| K823138 | CELL SCRAPER | Nov 29, 1982 | Substantially Equivalent |
| K803244 | ASSAY STRIPS | Feb 2, 1981 | Substantially Equivalent |
| K803242 | SEROCLUSTER EIA PLATES | Jan 28, 1981 | Substantially Equivalent |
| K803243 | SEROCLUSTER FLEXIBLE VINYL U & V PL. | Jan 28, 1981 | Substantially Equivalent |
| K800240 | SEROCLUSTER U AND V | Feb 13, 1980 | Substantially Equivalent |