FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CORNING CERTAIN -ISE
K Number: K851939
·
Decision Jun 14, 1985
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
301
Applicant Total
111
Review Days
42
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Basic Information
- Device Name
- CORNING CERTAIN -ISE
- K Number
- K851939
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Corning Medical & Scientific
- Date Received
- May 3, 1985
- Decision Date
- June 14, 1985
- Product Code
- JIX
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture | FDA class 2 | Clinical Chemistry |
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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 |
| K872076 | CORNING DISPOSABLE ROLLER BOTTLES | Jun 15, 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 |
| 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 |