Alkaline Phosphatase Isoenzyme System
FDA 510(k) K885024 · Ciba Corning Diagnostics Corp.
510(k) numberK885024
Submission
- Device name
- Alkaline Phosphatase Isoenzyme System
- Applicant
- Ciba Corning Diagnostics Corp.
East Walpole, MA, US - Received
- December 5, 1988
- Decision date
- February 17, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CIN – Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1050
- Specialty
- Clinical Chemistry
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| K962041 | Acs LH2 ImmunoassayCEP · Traditional | 06/21/1996SE |
| K961510 | Acs FRT4 ImmunoassayJJX · Traditional | 06/17/1996SE |
| K960246 | Liquid Cardiac Marker 1,2,3 AssayedJJT · Traditional | 04/23/1996SE |
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Questions and answers
When was Alkaline Phosphatase Isoenzyme System cleared by the FDA?
Alkaline Phosphatase Isoenzyme System (K885024) received a 510(k) decision of Substantially Equivalent on February 17, 1989, 74 days after the submission was received.
What is the product code of K885024?
The FDA product code is CIN – Electrophoretic Separation, Alkaline Phosphatase Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.