FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CORNING DISPOSABLE ROLLER BOTTLES
K Number: K872076
·
Decision Jun 15, 1987
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
2
Applicant Total
111
Review Days
17
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Basic Information
- Device Name
- CORNING DISPOSABLE ROLLER BOTTLES
- K Number
- K872076
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.2240
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Corning Medical & Scientific
- Date Received
- May 29, 1987
- Decision Date
- June 15, 1987
- Product Code
- KJB
- Advisory Committee
- Hematology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| KJB | Apparatus, Roller | FDA class 1 | Hematology |
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Other Clearances by Corning Medical & Scientific
| K Number | Device Name | ||
|---|---|---|---|
| K875122 | DISPOSABLE STERILE SYRINGE FILTERS | Jan 12, 1988 | Substantially Equivalent |
| K872273 | CORNING EASY WASH ELISA PLATES | Jul 7, 1987 | Substantially Equivalent |
| K863789 | CORNING ELISA PLATES | Oct 3, 1986 | Substantially Equivalent |
| K854024 | CORNING MAGIC MAB HCG RADIOIMMUNOASSAY | Nov 26, 1985 | Substantially Equivalent |
| K853634 | CORNING CELL WELLS-MULTIPLE WELL PLATES | Sep 16, 1985 | Substantially Equivalent |
| K851939 | CORNING CERTAIN -ISE | Jun 14, 1985 | Substantially Equivalent |
| K851329 | MAGIC MONOCLONAL ANTIBODY TSH(MAB TSH)RADIOIMMUNOA | Jun 13, 1985 | Substantially Equivalent |
| K850806 | CORNING BLOOD COLLECTION CAPILLARY TUBES | Mar 25, 1985 | Substantially Equivalent |
| K850617 | CORNING 780 FLUOROMETER/DENSITOMETER | Mar 12, 1985 | Substantially Equivalent |
| K844671 | CORNING DISPOSAL STERILE FILTER SYSTEM-NYLON | Feb 25, 1985 | Substantially Equivalent |