FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CELL SCRAPER
K Number: K823138
·
Decision Nov 29, 1982
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
12
Applicant Total
8
Review Days
35
Basic Information
- Device Name
- CELL SCRAPER
- K Number
- K823138
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.2240
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Corning Costar Corp.
- Date Received
- October 25, 1982
- Decision Date
- November 29, 1982
- Product Code
- KJA
- 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 |
|---|---|---|---|
| KJA | Flask, Tissue Culture | FDA class 1 | Hematology |
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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 |
| 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 |