FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SEROCLUSTER EIA PLATES
K Number: K803242
·
Decision Jan 28, 1981
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
65
Applicant Total
8
Review Days
36
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Basic Information
- Device Name
- SEROCLUSTER EIA PLATES
- K Number
- K803242
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2500
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Corning Costar Corp.
- Date Received
- December 23, 1980
- Decision Date
- January 28, 1981
- Product Code
- JTC
- Advisory Committee
- Microbiology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| JTC | Device, Microtiter Diluting/Dispensing | FDA class 1 | Microbiology |
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Other Clearances by Corning Costar Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K871559 | CELL LIFTER | May 15, 1987 | Substantially Equivalent |
| K860703 | U - STAR (MICRO-STAR) | May 6, 1986 | 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 |
| K803243 | SEROCLUSTER FLEXIBLE VINYL U & V PL. | Jan 28, 1981 | Substantially Equivalent |
| K800240 | SEROCLUSTER U AND V | Feb 13, 1980 | Substantially Equivalent |